# K180321: Aesculap Optilene Nonabsorbable Suture

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Mar 7, 2018 after 30 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954808 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133890: Aesculap Optilene Nonabsorbable Suture, Aesculap, Inc. (2014) Summary page 5.

## Indications for use
Optilene Nonabsorbable Polypropylene/Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Source page: https://510kreport.com/device/K180321
Methodology: https://510kreport.com/methodology