510(k) K965054 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PENCIL
| Applicant | Megadyne Medical Products, Inc., Draper UT, US |
| Decision | Substantially Equivalent, Jan 24, 1997 |
| Received | Dec 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2006 | Megadyne Medical Products, Inc Rocker Switch Electrosurgical Pencil with E-Z Clean Tip Terminated |
GEI | None listed |
| Apr 19, 2006 | Megadyne Medical Products, Inc Button Switch Electrosurgical Pencil with E-Z Clean Tip and Holster Terminated |
GEI | None listed |
| Apr 19, 2006 | Megadyne Medical Products, Inc Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster Terminated |
GEI | None listed |
| Apr 19, 2006 | Megadyne Medical Products, Inc Button Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster Terminated |
GEI | None listed |
| Apr 19, 2006 | Megadyne Medical Products, Inc Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster Terminated |
GEI | None listed |
| Apr 19, 2006 | Megadyne Medical Products, Inc Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster Terminated |
GEI | None listed |
| Apr 19, 2006 | Megadyne Medical Products, Inc Rocker Switch Electrosurgical Pencil with Holster Terminated |
GEI | None listed |
| Apr 19, 2006 | Megadyne Medical Products, Inc Button Switch Electrosurgical Pencil with Holster Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.