510(k) K913281 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
E-Z CLEAN LAPAROSCOPIC ELECTRODE
| Applicant | Megadyne Medical Products, Inc., Murray UT, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | Jul 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2013 | Megadyne Medical Products, Inc. E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyes Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.