# K171001: Monosyn Quick Synthetic Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Oct 23, 2017 after 202 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 K011375 (2001). 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)
- K011375: Aesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture, Aesculap, Inc. (2001) Summary page 4.

## Indications for use
Monosyn Quick Synthetic Absorbable Surgical Suture is intended for general soft tissue approximation of the skin and mucosa, where only short term wound support (6-7 days) is required. Monosyn Quick suture is not indicated for use in cardiovascular or neurosurgery.

Source page: https://510kreport.com/device/K171001
Methodology: https://510kreport.com/methodology