GCQ
5 FDA 510(k) clearances · Product code
95 daysmedian time to decision
386 days90th percentile
5clearances measured
FDA profile
- Official device name
- Endoscope, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2005: 4 · 2006: 2 · 2010: 4 · 2011: 5 · 2012: 18 · 2021: 15
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 |
|---|---|---|
| CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) (K920979) | Codman & Shurtleff, Inc. | 1993-03-23 |
| MEDILASE SERIES 2100 ENDOSCOPE (K900894) | Medical Laser, Inc. | 1990-06-22 |
| CODMAN FLEXIBLE ENDOSCOPE (K871978) | Codman & Shurtleff, Inc. | 1987-08-25 |
| TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. (K864960) | Cooper Lasersonics, Inc. | 1987-02-10 |
| VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE (K860771) | Van-Tec, Inc. | 1986-04-23 |
Track GCQ automatically
Every clearance here is in the API, with alerts when new ones post.