GDB
7 FDA 510(k) clearances · Product code
64 daysmedian time to decision
223 days90th percentile
7clearances measured
FDA profile
- Official device name
- Endoscope, Fiber Optic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1994: 2 · 1996: 2 · 1997: 2 · 2000: 1 · 2001: 1 · 2010: 3
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 |
|---|---|---|
| DESIGNS FOR VISION FIBEROPTIC LIGHT (K032283) | Designs For Vision, Inc. | 2003-08-20 |
| FLEXSCOPE (K961536) | Matrix Medica, Inc. | 1996-09-18 |
| ENDOSCOPE (K935818) | Cuda Products Co. | 1994-07-13 |
| OLYMPUS GF-UM3/EU-M3 (K882061) | Olympus Corp. | 1988-11-15 |
| FRITCH OPHTHALMIC ENDOSCOPE (K855151) | Regtec | 1986-02-19 |
| FOCUSCOPE UNIVERSAL SYSTEM (K843900) | Medical Diagnostics, Ca. | 1984-12-06 |
| PENTAX UPPER G.I. FIBERSCOPE, #FG-34 (K810007) | Pentax Precision Instrument Corp. | 1981-01-15 |
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Every clearance here is in the API, with alerts when new ones post.