GCF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Proctoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2001: 1
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 |
|---|---|---|
| PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS (K945209) | KARL STORZ Endoscopy-America, Inc. | 1995-03-06 |
| PROCTOSCOPE #501 (K790856) | C. Intl. | 1979-05-29 |
Track GCF automatically
Every clearance here is in the API, with alerts when new ones post.