# K102028: Neotract Anchor System Model TAS400

- Pathway: 510(k) (Special)
- Applicant: Neotract, Inc.
- Decided: Aug 4, 2010 after 16 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K972679 (1997). 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)
- K101252: Neotract Anchor System Model: Ref 11208, Neotract, Inc. (2010) Summary page 1.

## Indications for use
The NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.

Source page: https://510kreport.com/device/K102028
Methodology: https://510kreport.com/methodology