ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
FDA 510(k) clearance K020585 · decided 2002-07-13
Clearance details
- K-number
- K020585
- Device name
- ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
- Applicant
- Gyrus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-22
- Decision date
- 2002-07-13
- Days to decision
- 141 days
- Clearance type
- Traditional
- 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 PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device recall (Z-1175-06) | Gyrus Medical, Inc. | 2006-06-27 |