Product code FCX
- Device name
- Insufflator, Automatic Carbon-Dioxide For Endoscope
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240847 | MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. | 2024-10-30 |
| K230474 | EVA5 Insufflator | Palliare , Ltd. | 2023-03-24 |
| K202922 | END 200 Endoscopic Tubeset | Palliare , Ltd. | 2021-07-08 |
| K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020-06-23 |
| K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019-05-14 |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 | Fujifilm Corporation | 2018-05-25 |
| K162332 | Nexcore GI Insufflator | Nexcore Technology, LLC | 2016-09-29 |
| K133976 | FUJIFILM ENDOSCOPIC CO2 REGULATOR | Fujifilm Medical System U.S.A., Inc. | 2014-09-09 |
| K132192 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR | Bracco Diagnostic, Inc. | 2014-02-14 |
| K123047 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET | Bracco Diagnostic, Inc. | 2013-08-06 |
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | Byrne Medical, Inc. | 2012-06-20 |
| K111648 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR | Bracco Diagnostic, Inc. | 2011-11-03 |
| K090879 | INSUFLOW CO2IONSHIELD | Lexion Medical, LLC | 2009-07-23 |
| K063786 | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 | Olympus Medical Systems Corporation | 2007-03-05 |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | E-Z-Em, Inc. | 2005-12-27 |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | E-Z-Em, Inc. | 2003-04-16 |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | E-Z-Em, Inc. | 2002-02-19 |
| K945970 | INSUFFLATOR FILTER TUBING SET | Xylog Corp. | 1994-12-15 |
| K930581 | E-Z-FLATE | E-Z-Em, Inc. | 1994-07-01 |
| K935059 | INSUFFLATION TUBING SET, PHX500-082 | Phx Technologies Corp. | 1993-12-22 |
| K930508 | HIFLO FILTERED INSUFFLATION TUBING | W. J. Medical Instruments, Inc. | 1993-06-25 |
| K910716 | MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE | Richard Wolf Medical Instruments Corp. | 1991-04-16 |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | Keymed, Inc. | 1988-05-12 |
| K844689 | ENDOSCOPIC MANUAL AIR INSUFFLATOR | Jayco Pharmaceuticals | 1985-01-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842942017315 | PRIMED | priMED Medical Products Inc | 2025-07-14 |
| 10815112021570 | Protocol Administration Set With Flexi-Cuff Retention Tip | Bracco Diagnostics Inc. | 2025-05-16 |
| 04055207007778 | NA | Richard Wolf GmbH | 2024-08-19 |
| 04055207007761 | NA | Richard Wolf GmbH | 2024-08-19 |
| 04055207007754 | NA | Richard Wolf GmbH | 2024-08-19 |
| 10815112021235 | Protocol Touch Colon Insufflator | Bracco Diagnostics Inc. | 2023-08-31 |
| 10815112021266 | Protocol Accessory Cart | Bracco Diagnostics Inc. | 2023-07-07 |
| 10815112021242 | Protocol Touch Administration Set with Small Catheter and Retention Cuff | Bracco Diagnostics Inc. | 2023-06-29 |
| 10815112021280 | Protocol Administration Set with Small Catheter and Retention Cuff | Bracco Diagnostics Inc. | 2023-06-29 |
| 00724995180409 | NA | US Endoscopy | 2020-04-02 |
| 00724995180454 | NA | US Endoscopy | 2020-04-02 |
| 00724995180447 | NA | US Endoscopy | 2020-04-02 |
| 00724995180430 | NA | US Endoscopy | 2020-04-02 |
| 00724995180423 | NA | US Endoscopy | 2020-04-02 |
| 00724995180416 | NA | US Endoscopy | 2020-04-02 |
| 00724995180386 | NA | US Endoscopy | 2020-04-02 |
| 00724995180362 | CO2MPACT | US Endoscopy | 2020-04-02 |
| 00724995180355 | NA | US Endoscopy | 2020-04-02 |
| 00677964085574 | Gasjet CO2 Delivery System | MEDIVATORS INC. | 2017-05-04 |
| 00677964085567 | Pentax Irrigation Pump | MEDIVATORS INC. | 2017-05-04 |
| 00858701006162 | NOVADAQ®and PINPOINT® | Novadaq Technologies Inc | 2016-09-23 |
| 10815112020122 | Protocol Colon Insufflator | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021143 | Protocol Touch Colon Insufflator Demo Unit | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021136 | Protocol Colon Insufflator Demo Unit | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020177 | Protocol Administration Set with Small Catheter and Retention Cuff | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020146 | Protocol Touch Colon Insufflator | Bracco Diagnostics Inc. | 2016-09-19 |
| 00816765013076 | NA | Corporation Steris Canada | 2016-09-17 |
| 00816765013113 | NA | US Endoscopy | 2016-09-17 |
| 00816765013120 | NA | US Endoscopy | 2016-09-17 |
| 00816765013137 | NA | US Endoscopy | 2016-09-17 |