510(k) K072559 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SUCTION COAGULATOR
| Applicant | Megadyne Medical Products, Inc., Draper UT, US |
| Decision | Substantially Equivalent, Oct 5, 2007 |
| Received | Sep 11, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2023 | Megadyne Medical Products, Inc. MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Open, Classified |
GEI | None listed |
| Mar 7, 2014 | Megadyne Medical Products, Inc. Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box.
This device is intended to conduc Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.