# K180701: SafePath Suturing System

- Pathway: 510(k) (Traditional)
- Applicant: Safepath Medical, Inc.
- Decided: Jun 25, 2018 after 101 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: 5 generations back to K930586 (1993). 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)
- K161633: Rexlon, Rexsil, Sm Eng Co., Ltd. (2017) Summary page 4.
- K980123: Carter-Thomason Needle-Point Suture Passer Instrument Set, Louisville Laboratories, Inc. (1998) Summary page 4.
- (no number) USP non-absorbable silk suture: named in the summary without a submission number

## Most influential descendants
- K222944: SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K180701
Methodology: https://510kreport.com/methodology