TissueTak device
510(k) K203117
TissueTak device is a Class II device made by Via Surgical, Ltd., cleared under FDA 510(k) K203117 on 7 Jan 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203117 | Date7 Jan 2021 | StatusActive |
Official records
- FDA 510(k) database K203117
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GDW
- FDA applicant
- Via Surgical , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4750
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K203117
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| TissueTak™ AR-19021TT | AR-19021TT / AR-19021TT | 07290017155302 | Outer Diameter 5 mm; Length 20.9 cm | On the market |
| TissueTak™ AR-19021TT-1 | AR-19021TT-1 / AR-19021TT-1 | 07290017155364 | Outer Diameter 5 mm; Length 20.9 cm | On the market |
| TissueTak™ AS-19021TT | AS-19021TT / AS-19021TT | 07290017155340 | Outer Diameter 5 mm; Length 20.9 cm | On the market |
| TissueTak™ AS-19022TT | AS-19022TT / AS-19022TT | 07290017155357 | Outer Diameter 5 mm; Length 20.9 cm | On the market |
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