# K181320: Caprolon

- Pathway: 510(k) (Traditional)
- Applicant: Resorba Medical GmbH
- Decided: Sep 18, 2018 after 123 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 K010672 (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)
- K010672: Monograms Synthetic Monofilament Absorbable Suture, Gramsmed, LLC (2001) Summary page 4.

## Indications for use
CAPROLON® is Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures

Source page: https://510kreport.com/device/K181320
Methodology: https://510kreport.com/methodology