FasTouch Fixation System
by Via Surgical, Ltd. 2 variants
510(k) K162252
FasTouch Fixation System is a Class II device made by Via Surgical, Ltd., cleared under FDA 510(k) K162252 on 14 Nov 2016, 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 | NumberK162252 | Date14 Nov 2016 | StatusActive |
Official records
- FDA 510(k) database K162252
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- Withdrawn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 K162252
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 | |||
|---|---|---|---|---|
| FasTouch™ FTP25 | FTP25 / FTP25 | 07290017155104 | Outer Diameter 5 mm; Length 37 cm | On the market |
| FasTouch™ FTPC10 | FTPC10 / FTPC10 | 07290017155111 | Outer Diameter 5 mm; Length 37 cm | On the market |
| FasTouch™ SFTP25 | SFTP25 / SFTP25 | 07290017155012 | Length 37 cm; Outer Diameter 5 mm | On the market |
| FasTouch™ SFTPC10 | SFTPC10 / SFTPC10 | 07290017155043 | Length 37 cm; Outer Diameter 5 mm | On the market |
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