# K160761: DW-1C

- Pathway: 510(k) (Traditional)
- Applicant: Dongwon Medical Co., Ltd.
- Decided: Nov 22, 2016 after 246 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.
1 later device descends from it; 1 cites it directly.
0 of 21 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.

## Most influential descendants
- K190437: Delta 3300 (2019), 0 descendants of its own

## Indications for use
The DW-1 C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Source page: https://510kreport.com/device/K160761
Methodology: https://510kreport.com/methodology