510(k) K101095 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
| Applicant | Wilson-Cook Medical, Inc., Winston Salem NC, US |
| Decision | Substantially Equivalent, Jul 19, 2010 |
| Received | Apr 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2011 | Cook Endoscopy DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105
This device is intended to guide both optical and accessory devices for diagnostic and therapeuti Terminated |
FGE | None listed |
| Jan 19, 2011 | Cook Endoscopy DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105
This device is intended to guide both optical and accessory devices for diagnostic Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.