510(k) K140459 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM
| Applicant | Conmed Corporation, Utica NY, US |
| Decision | Substantially Equivalent, Jul 11, 2014 |
| Received | Feb 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2015 | ConMed Corporation Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.