510(k) K961940 ยท GCJ Laparoscope, General & Plastic Surgery
INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
| Applicant | Innerdyne, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 10, 1996 |
| Received | May 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961940
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Covidien, LP Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010 Open, Classified |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.