510(k) K851962 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ZIMMON BILIARY STENT SET
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Dec 17, 1985 |
| Received | May 3, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2008 | Cook Endoscopy Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC Terminated |
FGE | None listed |
| Sep 23, 2008 | Cook Endoscopy Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Used Terminated |
FGE | None listed |
| Jun 28, 2005 | Wilson-Cook Medical Inc CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx On Terminated |
FGE | None listed |
| Jul 20, 2004 | Wilson-Cook Medical Inc Biliary Stent Introducer Set Terminated |
FGE | None listed |
| Jan 14, 2004 | Wilson-Cook Medical Inc Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separat Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.