# K081002: Monoglyde, Absorbable (Poliglecaprone 25) Suture

- Pathway: 510(k) (Traditional)
- Applicant: Sutures India Pvt., Ltd.
- Decided: Jun 9, 2008 after 62 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: 1 generation back to K930772 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930772: Ethicon* Monocryl (Poliglecaprone 25) Suture, ETHICON, Inc. (1994) Summary page 1.
- K072646: Unicaprone, United Medical Industries Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K130083: Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture (2013), 1 descendant of its own
- K232372: Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (2024), 0 descendants of its own

## Indications for use
MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE, STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACiD 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES

Source page: https://510kreport.com/device/K081002
Methodology: https://510kreport.com/methodology