510(k) K940909 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE
| Applicant | Debusk Technology Corp., Powell TN, US |
| Decision | Substantially Equivalent, Mar 30, 1994 |
| Received | Feb 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940909
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2018 | DeRoyal Industries Inc DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502
Product Usage: general surgical Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.