WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
FDA 510(k) clearance K023903 · decided 2003-02-20
Clearance details
- K-number
- K023903
- Device name
- WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-22
- Decision date
- 2003-02-20
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PKL
- 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 |
|---|---|---|
| Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usag recall (Z-2691-2011) | Cook Endoscopy | 2011-06-28 |