510(k) K050923 ยท JOS Electrode, Electrosurgical
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR
| Applicant | Conmed Linvatec, Largo FL, US |
| Decision | Substantially Equivalent, May 18, 2005 |
| Received | Apr 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050923
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2009 | Linvatec Corp. dba ConMed Linvatec REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908.
ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.