EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS
FDA 510(k) clearance K031078 · decided 2003-05-16
Clearance details
- K-number
- K031078
- Device name
- EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS
- Applicant
- Gyrus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-04
- Decision date
- 2003-05-16
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps recall (Z-0100-2015) | Gyrus Medical, Inc | 2014-10-21 |