# K162366: Omega VL

- Pathway: 510(k) (Traditional)
- Applicant: Ov World Co., Ltd.
- Decided: Mar 2, 2018 after 556 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K014153 (2002). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130191: MINT, Hans Biomed Corporation (2013) Summary page 4.

## Indications for use
Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Source page: https://510kreport.com/device/K162366
Methodology: https://510kreport.com/methodology