# K190264: Viola

- Pathway: 510(k) (Traditional)
- Applicant: Meditime Co., Ltd.
- Decided: Aug 15, 2019 after 188 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)
- K133420: Tranquill Barbed Device, Surgical Specialties Corp. Dba Angiotech (2013) Summary page 4.

## Indications for use
VIOLA barbed suture comprised of dyed polydioxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate

Source page: https://510kreport.com/device/K190264
Methodology: https://510kreport.com/methodology