# K130083: Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corp.
- Decided: Jul 17, 2013 after 184 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960653 (1996). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100461: PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut, Riverpoint Medical (2010) Summary page 1.
- K081002: Monoglyde, Absorbable (Poliglecaprone 25) Suture, Sutures India Pvt., Ltd. (2008) Summary page 1.
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified), ETHICON, Inc. (1996) Summary page 2.
- K964072: Monocryl (Poliglecaprone 25) Suture, Undyed, ETHICON, Inc. (1996) Summary page 2.

## Most influential descendants
- K232372: Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (2024), 0 descendants of its own

## Indications for use
Demetech Absorbable Poliglecaprone 25 Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery and neurological tissue.

Source page: https://510kreport.com/device/K130083
Methodology: https://510kreport.com/methodology