# K261484: Tissue Approximation System

- Pathway: 510(k) (Special)
- Applicant: Tas Medical, Inc.
- Decided: Jun 3, 2026 after 29 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K123034 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220980: Tissue Approximation System (TAS), Tas Medical, Inc. (2023) Summary page 5.

## 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/K261484
Methodology: https://510kreport.com/methodology