ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
FDA 510(k) clearance K113062 · decided 2012-08-21
Clearance details
- K-number
- K113062
- Device name
- ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
- Applicant
- Endoservice Optical Instruments GmbH
- Decision
- Substantially Equivalent
- Date received
- 2011-10-14
- Decision date
- 2012-08-21
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- FBP
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tuttlingen, Baden Wurttemberg, DE
- Third-party review
- No
- Expedited review
- No
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.