510(k) K031081 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
| Applicant | Gyrus Medical, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, May 21, 2003 |
| Received | Apr 4, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2014 | Gyrus Medical, Inc GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm
REF 3345PK - PKS MOLly Forceps 5mm/45cm
REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm
REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm
REF 3 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.