WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
FDA 510(k) clearance K974018 · decided 1998-01-20
Clearance details
- K-number
- K974018
- Device name
- WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-22
- Decision date
- 1998-01-20
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FHN
- Device class
- 2
- Regulation number
- 876.4400
- 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 |
|---|---|---|
| Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station R recall (Z-0091-2011) | Cook Endoscopy | 2010-10-19 |