ROTATABLE POLYPECTOMY SNARE POS-1
FDA 510(k) clearance K851958 · decided 1985-07-25
Clearance details
- K-number
- K851958
- Device name
- ROTATABLE POLYPECTOMY SNARE POS-1
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-03
- Decision date
- 1985-07-25
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4 recall (Z-1059-2009) | Cook Endoscopy | 2009-03-10 |
| AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station recall (Z-0906-04) | Wilson-Cook Medical Inc | 2004-07-20 |