# K222944: SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture

- Pathway: 510(k) (Traditional)
- Applicant: Safepath Medical, Inc.
- Decided: Oct 18, 2024 after 753 days
- Product code: GAP (Suture, Nonabsorbable, Silk)
- Device class: 2
- Regulation: 21 CFR 878.5030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930586 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180701: SafePath Suturing System, Safepath Medical, Inc. (2018) Summary page 5.
- K161633: Rexlon, Rexsil, Sm Eng Co., Ltd. (2017) Summary page 6.
- K173747: Rexlene, Sm Eng Co., Ltd. (2018) Summary page 6.

## Indications for use
The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues. The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues. The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.

Source page: https://510kreport.com/device/K222944
Methodology: https://510kreport.com/methodology