510(k) K133726 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
| Applicant | Megadyne Medical Products, Inc., Draper UT, US |
| Decision | Substantially Equivalent, Jan 24, 2014 |
| Received | Dec 6, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133726
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode Open, Classified |
GEI | None listed |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | None listed |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | None listed |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | None listed |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.