510(k) K171223 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Quantum TTC Biliary Balloon Dilator
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Jun 16, 2017 |
| Received | Apr 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171223
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree Open, Classified |
FGE | None listed |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree Open, Classified |
FGE | None listed |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree Open, Classified |
FGE | None listed |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree Open, Classified |
FGE | None listed |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree Open, Classified |
FGE | None listed |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree Open, Classified |
FGE | None listed |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree Open, Classified |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.