510(k) K152081 ยท FZP Clip, Implantable
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
| Applicant | Teleflexmedical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Aug 26, 2015 |
| Received | Jul 27, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2017 | Teleflex Medical WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.