EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
FDA 510(k) clearance K060475 · decided 2006-03-17
Clearance details
- K-number
- K060475
- Device name
- EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-02-23
- Decision date
- 2006-03-17
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- ODB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- Yes
- 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 |
|---|---|---|
| ScopeSeal Duodenoscope Protective Device (K183171) | Gi Scientific, LLC | 2019-10-08 |
| LumenR Tissue Retractor System (K153698) | Lumenr, LLC | 2016-04-19 |
| MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 (K080550) | Minos Medical | 2008-06-10 |
| TROCARS,CANNULAE,SHEATHS,OBTURATORS (K943697) | Karl Storz Endoskop GmbH | 1994-09-14 |
Recalls involving this device
No recalls on record reference this clearance.