FGM — Probe And Director, Gastro-Urology Class I
FDA product code FGM covers "Probe And Director, Gastro-Urology", a Class I medical device regulated under 21 CFR 876.4730. Submissions are reviewed by the Gastroenterology, Urology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FGM
- Device Class
- Class I
- Regulation Number
- 876.4730
- Submission Type
- 510(k) Exempt
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K041732 | Blue Torch Medical Technologies | CAVERMAP SURGICAL AID | Sep 21, 2004 |
| K031527 | Blue Torch Medical Technologies | MODIFICATION TO CAVERMAP SURGICAL AID | Jun 5, 2003 |
| K010098 | Uromed | MODIFICATION TO CAVERMAP SURGICAL AID | Feb 1, 2001 |
| K993436 | Uromed | CAVERMAP SURGICAL AID | Feb 11, 2000 |
| K944384 | Regulatory And Marketing Services | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Feb 15, 1995 |
| K944379 | Regulatory And Marketing Services | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 |
| K944378 | Regulatory And Marketing Services | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 |