# K993998: NYLON

- Pathway: 510(k) (Traditional)
- Applicant: Trading Consultants and Distributors Intl., Inc.
- Decided: Feb 4, 2000 after 72 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
No predicates in its family tree.
14 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) DERMALON® Non-Absorbable Polyamide Surgical Sutures: named in the summary without a submission number
- (no number) Ethilon® Nonabsorbable Polyamide Surgical Suture: named in the summary without a submission number

## Most influential descendants
- K060471: FSSB Nylon Surgical Sutures (2006), 10 descendants of its own
- 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

## Indications for use
NYLON is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K993998
Methodology: https://510kreport.com/methodology