FDA product code FBP: Telescope, Rigid, Endoscopic
FBP is the FDA product code for telescope, rigid, endoscopic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FBP, from 5 different applicants. The average 510(k) review took 145 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Telescope, Rigid, Endoscopic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FBP clearance
Top FBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Winter & Ibe GmbH | 1 | 2015-11-24 |
| Endoservice Optical Instruments GmbH | 1 | 2012-08-21 |
| Acmi Corporation | 1 | 2003-09-02 |
| Richard Wolf Medical Instruments Corp. | 1 | 1999-03-05 |
| V. Mueller O.V. Baxter Healthcare Corp. | 1 | 1976-08-30 |
Most recent FBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151191 | Olympus Winter & Ibe GmbH | OES ELITE Telescopes, Protective Tube | 2015-11-24 | 204 |
| K113062 | Endoservice Optical Instruments GmbH | ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES | 2012-08-21 | 312 |
| K031758 | Acmi Corporation | ACMI M4 TELESCOPES | 2003-09-02 | 88 |
| K984607 | Richard Wolf Medical Instruments Corp. | PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX | 1999-03-05 | 67 |
| K760177 | V. Mueller O.V. Baxter Healthcare Corp. | TELESCOPE, RIGID ENDOSCOPE | 1976-08-30 | 55 |
Recalls for FBP devices
openFDA lists no recalls for product code FBP.
Frequently asked questions
What is FDA product code FBP?
FBP is the FDA product code for telescope, rigid, endoscopic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FBP?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FBP?
Across 5 cleared submissions the average was 145 days from receipt to decision (median 88).
Which companies have the most FBP clearances?
Olympus Winter & Ibe GmbH (1); Endoservice Optical Instruments GmbH (1); Acmi Corporation (1); Richard Wolf Medical Instruments Corp. (1); V. Mueller O.V. Baxter Healthcare Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FBP
- Run a recall and safety report across every FBP manufacturer
- Watch product code FBP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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