510(k) K133414 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
REPROCESSED CLOSURE SYSTEM
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Jan 22, 2014 |
| Received | Nov 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2015 | CooperSurgical, Inc. Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery. Terminated |
NLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.