Creo Medical
GUDID 05060359560025
A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.
CREO MEDICAL LIMITED
Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument Endoscopic electrosurgical/microwave submucosal lift/resection instrument| Primary Device ID | 05060359560025 |
| NIH Device Record Key | 17a07c0e-4ef9-4eec-ac46-a1cfb6ed6912 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Creo Medical |
| Version Model Number | 7-RS2-001 |
| Company DUNS | 733853373 |
| Company Name | CREO MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Catheter Length | 2.3 Meter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
| Outer Diameter | 3.7 Millimeter |
| Catheter Length | 2.3 Meter |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060359560025 [Primary] |
| GS1 | 05060359560049 [Package] Package: Shipper Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171983
FDA Product Code
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2018-11-14 |
On-Brand Devices [Creo Medical]
| 05060359560124 | A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical syste |
| 05060359560087 | A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical syste |
| 05060359560063 | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed |
| 05060359560025 | A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal l |
Trademark Results [Creo Medical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CREO MEDICAL 79267981 not registered Live/Pending |
Creo Medical Ltd 2019-07-31 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.