# K023030: Demetech Polyester Nonabsorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corp.
- Decided: Jun 18, 2003 after 280 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: 1 generation back to K003590 (2001). 1 ancestor in all.
19 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003590: Grams Polyester Nonabsorbable Suture, Gramsmed, LLC (2001) Summary page 1.

## Most influential descendants
- K093679: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide  Model Various LAA0 (2010), 18 descendants of its own
- K122276: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip (2012), 15 descendants of its own
- K153500: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip (2016), 10 descendants of its own
- K173031: AtriClip LAA Exclusion System with Preloaded PRO·V Clip (2017), 9 descendants of its own
- K180010: AtriClip FLEX-V (2018), 8 descendants of its own

## Indications for use
The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation andor ligation, including use in cardiovascular and ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K023030
Methodology: https://510kreport.com/methodology