# K220980: Tissue Approximation System (TAS)

- Pathway: 510(k) (Traditional)
- Applicant: Tas Medical, Inc.
- Decided: Jul 5, 2023 after 457 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K123034 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123034: Vital Sutures Suturex Cirugia Peruana Sutumed, Unilene Sac (2013) Summary page 4.

## Most influential descendants
- K261484: Tissue Approximation System (2026), 0 descendants of its own

## Recalls of this device
- Jan 27, 2025 · Class II · Z-1294-2025: Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution f

## Indications for use
The Tissue Approximation System (TAS) is indicated for use in soft tissue approximation, including use in general surgery procedures such as minimally invasive ventral hernia and abdominal wall closure less than 10cm, but not for use in ophthalmic, neurologic, or cardiovascular procedures.

Source page: https://510kreport.com/device/K220980
Methodology: https://510kreport.com/methodology