510(k) K113062
- Device
- ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
- Applicant
- ENDOSERVICE OPTICAL INSTRUMENTS GMBH
- 510(k) number
- K113062
- Product code
- FBP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-21
- Date received
- 2011-10-14
- Regulation
- 876.1500
- Classification name
- Telescope, Rigid, Endoscopic
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREA PECSI
- Address
- Schwarzwaldstrasse 5 Tuttlingen, Baden Wurttemberg DE 78532 78532
FDA Registration Numbers#
- 3013247477
- 3014279513
- 3008386005
- 3010041511
- 3024021261
- 9610773
- 9611102
- 3011137372
Source Documents#
Other 510(k) Records For Product Code FBP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151191 | OES ELITE Telescopes, Protective Tube | Olympus Winter & Ibe GmbH | 2015-11-24 |
| K031758 | ACMI M4 TELESCOPES | Acmi Corporation | 2003-09-02 |
| K984607 | PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX | Richard Wolf Medical Instruments Corp. | 1999-03-05 |
| K760177 | TELESCOPE, RIGID ENDOSCOPE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 |
Legacy Summary#
summary
FDA Review#
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