GYRUS OPEN FORCEPS
FDA 510(k) clearance K024286 · decided 2003-11-17
Clearance details
- K-number
- K024286
- Device name
- GYRUS OPEN FORCEPS
- Applicant
- Gyrus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-23
- Decision date
- 2003-11-17
- Days to decision
- 329 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
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is i recall (Z-0632-2010) | Gyrus ACMI Corporation | 2010-01-14 |
| Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device is recall (Z-0633-2010) | Gyrus ACMI Corporation | 2010-01-14 |
| Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device is i recall (Z-0634-2010) | Gyrus ACMI Corporation | 2010-01-14 |
| Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The devic recall (Z-0635-2010) | Gyrus ACMI Corporation | 2010-01-14 |
| Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The dev recall (Z-0636-2010) | Gyrus ACMI Corporation | 2010-01-14 |
| Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The devic recall (Z-0637-2010) | Gyrus ACMI Corporation | 2010-01-14 |