Telescope, Rigid, Endoscopic
The Rigid Endoscopic Telescope (product code FBP) is an optical component of a rigid endoscope system that provides the lens array used for visualization within body cavities during endoscopic procedures. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- FBP
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151191 | OES ELITE Telescopes, Protective Tube | Nov 24, 2015 | Substantially Equivalent | Olympus Winter & Ibe GmbH |
| K113062 | ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES | Aug 21, 2012 | Substantially Equivalent | Endoservice Optical Instruments GmbH |
| K031758 | ACMI M4 TELESCOPES | Sep 02, 2003 | Substantially Equivalent | Acmi Corporation |
| K984607 | PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX | Mar 05, 1999 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K760177 | TELESCOPE, RIGID ENDOSCOPE | Aug 30, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.