# K080684: WG-Surgical Sutures with Needle

- Pathway: 510(k) (Traditional)
- Applicant: Foosin Medical Supplies, Inc.
- Decided: Jun 9, 2008 after 91 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: 3 generations back to K930586 (1993). 15 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041514: Truesilk Non-Absorbable Silk Surgical Suture, Sutures India Private Limited (2005) Summary page 2.
- K070243: Sutralene Polypropylene Sutures, Visionary Medical Supplies, Inc. (2007) Summary page 2.
- K060165: Axyaflex Polyester Suture, Axya Medical, Inc. (2006) Summary page 3.
- K060471: FSSB Nylon Surgical Sutures, Fssb Chirurgische Nadeln GmbH (2006) Summary page 3.

## Most influential descendants
- 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
- K232355: Non absorbable Surgical Silk Suture (2024), 0 descendants of its own

## Indications for use
Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Nonabsorbable Polypropylene Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.

Source page: https://510kreport.com/device/K080684
Methodology: https://510kreport.com/methodology