FGC
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Urethroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2000: 1 · 2022: 33 · 2023: 346 · 2024: 455 · 2025: 560 · 2026: 362
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 |
|---|---|---|
| DIRECTVISION GUIDE SYSTEM (K091600) | Percuvision, LLC | 2009-08-25 |
| KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES (K945907) | KARL STORZ Endoscopy-America, Inc. | 1995-05-12 |
| GYNECOLOGICAL CYSTO/URETHROSCOPE (K800913) | Kli | 1980-05-14 |
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Every clearance here is in the API, with alerts when new ones post.