510(k) K002021 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Aug 24, 2000 |
| Received | Jul 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002021
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.