URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
FDA 510(k) clearance K912120 · decided 1991-08-07
Clearance details
- K-number
- K912120
- Device name
- URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-14
- Decision date
- 1991-08-07
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FBN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. Th recall (Z-0905-2025) | Olympus Corporation of the Americas | 2025-01-16 |