510(k) K003337 ยท FZP Clip, Implantable
HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
| Applicant | Weck Closure Systems, Research Triangle Park NC, US |
| Decision | Substantially Equivalent, Dec 21, 2000 |
| Received | Oct 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2006 | Teleflex Medical Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium large size, non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges per sales unit, 12 sales units per case; Mfg. by W Terminated |
FZP | None listed |
| Jun 9, 2006 | Teleflex Medical Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size, non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges per sales unit, 12 sales units per case; Mfg. by Weck Clos Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.