OES ELITE Telescopes, Protective Tube
FDA 510(k) clearance K151191 · decided 2015-11-24
Clearance details
- K-number
- K151191
- Device name
- OES ELITE Telescopes, Protective Tube
- Applicant
- Olympus Winter & Ibe GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-05-04
- Decision date
- 2015-11-24
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- FBP
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hamburg, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.