510(k) K945765 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HIGH TEMPERATURE CAUTERY
| Applicant | Aaron Medical Industries, St. Petersburg FL, US |
| Decision | Substantially Equivalent, Jan 30, 1995 |
| Received | Nov 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2004 | Biomet, Inc. Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.