TI CLIP APPLIER
FDA 510(k) clearance K034029 · decided 2004-03-05
Clearance details
- K-number
- K034029
- Device name
- TI CLIP APPLIER
- Applicant
- Gyrx, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-12-29
- Decision date
- 2004-03-05
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- NJC
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VASCLIP (K021745) | Vmbc, LLC | 2002-08-20 |
Recalls involving this device
No recalls on record reference this clearance.