# K192420: Crownjun Nylon Suture

- Pathway: 510(k) (Traditional)
- Applicant: Kono Seisakusho Co., Ltd.
- Decided: May 29, 2020 after 268 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954808 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151165: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture, Aesculap, Inc. (2016) Summary page 4.

## Most influential descendants
- K221280: Vesseal (2022), 0 descendants of its own

## Indications for use
CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues.

Source page: https://510kreport.com/device/K192420
Methodology: https://510kreport.com/methodology