# K203117: TissueTak device

- Pathway: 510(k) (Traditional)
- Applicant: Via Surgical, Ltd.
- Decided: Jan 7, 2021 after 83 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913469 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181668: FasTouch Absorbable Fixation System, Via Surgical, Ltd. (2019) Summary page 4.

## Indications for use
The TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.

Source page: https://510kreport.com/device/K203117
Methodology: https://510kreport.com/methodology