FGM
7 FDA 510(k) clearances · Product code
122 daysmedian time to decision
161 days90th percentile
7clearances measured
FDA profile
- Official device name
- Probe And Director, Gastro-Urology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1994: 1 · 1995: 1 · 1996: 2 · 1998: 2 · 2004: 2 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CAVERMAP SURGICAL AID (K041732) | Blue Torch Medical Technologies | 2004-09-21 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K031527) | Blue Torch Medical Technologies | 2003-06-05 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K010098) | Uromed Corp. | 2001-02-01 |
| CAVERMAP SURGICAL AID (K993436) | Uromed Corp. | 2000-02-11 |
| ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (K944379) | Regulatory & Marketing Services, Inc. | 1995-02-15 |
| ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (K944378) | Regulatory & Marketing Services, Inc. | 1995-02-15 |
| ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (K944384) | Regulatory & Marketing Services, Inc. | 1995-02-15 |
Track FGM automatically
Every clearance here is in the API, with alerts when new ones post.