OLYMPUS SD SERIES SNARES
FDA 510(k) clearance K955650 · decided 1996-03-29
Clearance details
- K-number
- K955650
- Device name
- OLYMPUS SD SERIES SNARES
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-12
- Decision date
- 1996-03-29
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- FDI
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/ recall (Z-2236-2010) | Olympus America Inc. | 2010-08-18 |