# K211307: GalaSTITCH Absorbable Monofilament Suture

- Pathway: 510(k) (Special)
- Applicant: Tepha, Inc.
- Decided: May 27, 2021 after 28 days
- Product code: NWJ (Suture, Recombinant Technology)
- Device class: 2
- Regulation: 21 CFR 878.4494
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K082178 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082178: Tephaflex Absorbable Suture, Tepha, Inc. (2008) Summary page 4.

## Indications for use
GalaSTITCH™ Absorbable Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.

Source page: https://510kreport.com/device/K211307
Methodology: https://510kreport.com/methodology