510(k) K082643 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
| Applicant | Depuy Mitek, A Johnson & Johnson Company, Raynham MA, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Sep 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece
Catalog Number: 227305
The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for r Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Side Effect Electrode (integrated)
Product Code: 227301
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrod Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.