Tissue Approximation System (TAS)
FDA 510(k) clearance K220980 · decided 2023-07-05
Clearance details
- K-number
- K220980
- Device name
- Tissue Approximation System (TAS)
- Applicant
- Tas Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-04
- Decision date
- 2023-07-05
- Days to decision
- 457 days
- Clearance type
- Traditional
- Product code
- GAR
- Device class
- 2
- Regulation number
- 878.5020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP recall (Z-1294-2025) | TAS Medical Inc | 2025-03-06 |