# K070243: Sutralene Polypropylene Sutures

- Pathway: 510(k) (Abbreviated)
- Applicant: Visionary Medical Supplies, Inc.
- Decided: Apr 17, 2007 after 82 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P16374: Ethicon PROLENE Nonabsorbable polypropylene sutures. Number could not be read Summary page 1.

## Most influential descendants
- K080684: WG-Surgical Sutures with Needle (2008), 9 descendants of its own
- K161633: Rexlon, Rexsil (2017), 4 descendants of its own
- K173747: Rexlene (2018), 1 descendant of its own
- K180701: SafePath Suturing System (2018), 1 descendant of its own
- 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 Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

Source page: https://510kreport.com/device/K070243
Methodology: https://510kreport.com/methodology