Definition: Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
| Device Type ID | 1735 |
| Device Name | Endoscopic Injection Needle, Gastroenterology-urology |
| Physical State | Needle And Accessories To Needle. Does Not Include Pneumoperitoneum Needles |
| Technical Method | Instrument Guided Through Endoscope To Puncture Desired Tissue |
| Target Area | Gi And Gu Tissues |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FBK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1735 |
| Device | Endoscopic Injection Needle, Gastroenterology-urology |
| Product Code | FBK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CARBON MEDICAL TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO-TECH (NAN JING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 33 |
Adverse Event Without Identified Device Or Use Problem | 27 |
Material Separation | 2 |
Device Handling Problem | 1 |
Difficult To Position | 1 |
Dull, Blunt | 1 |
Material Integrity Problem | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 68 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | US Endoscopy Group Inc | II | Oct-19-2016 |