510(k) K123366 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SURGITRON 4.0 DUAL RF S5-IEC
| Applicant | Ellman International, Inc., Oceanside NY, US |
| Decision | Substantially Equivalent, Jul 12, 2013 |
| Received | Oct 31, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2016 | Ellman International, Inc. ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE
The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpiec Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.