# K930586: Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Dec 17, 1993 after 316 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.
28 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981582: Surgilon, Dermalon, & Ophthalon (1998), 27 descendants of its own
- K110663: Pairetex Optimized Composite Mesh (Pco-FX Refrences) (2011), 12 descendants of its own
- K131969: Symbotex (TM) Composite Mesh (2013), 10 descendants of its own
- K060471: FSSB Nylon Surgical Sutures (2006), 10 descendants of its own
- K080684: WG-Surgical Sutures with Needle (2008), 9 descendants of its own

Source page: https://510kreport.com/device/K930586
Methodology: https://510kreport.com/methodology