# K060471: FSSB Nylon Surgical Sutures

- Pathway: 510(k) (Abbreviated)
- Applicant: Fssb Chirurgische Nadeln GmbH
- Decided: Jul 26, 2006 after 153 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: 2 generations back to K930586 (1993). 4 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993998: NYLON, Trading Consultants and Distributors Intl., Inc. (2000) Summary page 3.
- K981582: Surgilon, Dermalon, & Ophthalon, Davis & Geck, Inc. (1998) Summary page 3.
- K031531: S&T Microsurgical Suture, S & T AG (2003) Summary page 3.

## 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
FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K060471
Methodology: https://510kreport.com/methodology