510(k) K081791 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
E-Z CLEAN ELECTROSURGICAL ELECTRODE
| Applicant | Megadyne Medical Products, Inc., Draper UT, US |
| Decision | Substantially Equivalent, Oct 21, 2008 |
| Received | Jun 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2009 | Megadyne Medical Products, Inc. E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07* Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.