510(k) K943055 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES
| Applicant | Megadyne Medical Products, Inc., Draper UT, US |
| Decision | Substantially Equivalent, Dec 21, 1994 |
| Received | Jun 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2003 | Megadyne Medical Products, Inc Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE Terminated |
GEI | None listed |
| Jan 30, 2003 | Megadyne Medical Products, Inc Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.