FBP
5 FDA 510(k) clearances · Product code
88 daysmedian time to decision
312 days90th percentile
5clearances measured
FDA profile
- Official device name
- Telescope, Rigid, Endoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2008: 5 · 2009: 4 · 2010: 10 · 2011: 12 · 2012: 11 · 2013: 6
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 |
|---|---|---|
| OES ELITE Telescopes, Protective Tube (K151191) | Olympus Winter & Ibe GmbH | 2015-11-24 |
| ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES (K113062) | Endoservice Optical Instruments GmbH | 2012-08-21 |
| ACMI M4 TELESCOPES (K031758) | Acmi Corporation | 2003-09-02 |
| PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX (K984607) | Richard Wolf Medical Instruments Corp. | 1999-03-05 |
| TELESCOPE, RIGID ENDOSCOPE (K760177) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 |
Track FBP automatically
Every clearance here is in the API, with alerts when new ones post.