510(k) K031080 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS
| Applicant | Gyrus Medical, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, May 16, 2003 |
| Received | Apr 4, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2013 | Gyrus Medical, Inc GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO.
GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO.
The Dissectors are Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.