FGI — Catheter, Urethrographic, Male Class II
FDA product code FGI covers "Catheter, Urethrographic, Male", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FGI
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K023019 | vomed volzer medizintechnik gmbh and | VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 | December 10, 2002 |
| K013360 | neoseed technology | DFINER UROLOGICAL CATHETER | February 20, 2002 |
| K810370 | vance products | POLLACK CHAIN CYSOURETHROGRAM SET | March 20, 1981 |