510(k) K120476 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MACROLYTE DISPERSIVE ELECTRODE
| Applicant | Conmed Corporation, Centennial CO, US |
| Decision | Substantially Equivalent, Jun 12, 2012 |
| Received | Feb 16, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2019 | CooperSurgical, Inc. LEEP Return Patient Pads (10/ box)
Model # 6050Pl
used in electrosurgical procedures. Terminated |
GEI | None listed |
| Jun 4, 2014 | ConMed Corporation MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.