ZIMMON BILIARY STENT SET
FDA 510(k) clearance K851962 · decided 1985-12-17
Clearance details
- K-number
- K851962
- Device name
- ZIMMON BILIARY STENT SET
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-03
- Decision date
- 1985-12-17
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- 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 |
|---|---|---|
| Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposab recall (Z-2331-2008) | Cook Endoscopy | 2008-09-23 |
| Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single use recall (Z-2332-2008) | Cook Endoscopy | 2008-09-23 |
| CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps recall (Z-0940-05) | Wilson-Cook Medical Inc | 2005-06-28 |
| Biliary Stent Introducer Set recall (Z-0908-04) | Wilson-Cook Medical Inc | 2004-07-20 |
| Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, ( recall (Z-0347-04) | Wilson-Cook Medical Inc | 2004-01-14 |