# K981582: Surgilon, Dermalon, & Ophthalon

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Jul 13, 1998 after 70 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930586 (1993). 1 ancestor in all.
27 later devices descend from it; 5 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)
- K930586: Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut, Davis & Geck, Inc. (1993) Summary page 2.

## Most influential descendants
- 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
- K142908: Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh (2014), 5 descendants of its own

## Recalls of this device
- Jun 24, 2026 · Class II · Z-2920-2026: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalm
- Dec 21, 2023 · Class II · Z-0844-2024: Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such 
- Dec 2, 2022 · Class II · Z-1172-2023: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
- Dec 2, 2022 · Class II · Z-1178-2023: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
- Jun 3, 2011 · Not classified · Z-2821-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2820-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2823-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2822-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2824-2011: Potential for the sterile barrier to be breached compromising the sterility of the product

## Indications for use
Indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in Cardiovascular, Ophthalmic and Neural tissue. Surgilon (polyamide), Dermalon, Ophthalon are both braided and monofilament sutures available in white or dyed (black or blue) with a Logwood extract. These sutures are available in various lengths, diameters and quantities with or without surgical needles. These sutures are not absorbed, progressive hydrolysis of the nylon in-vivo may result in gradual loss of its tensile strength.

Source page: https://510kreport.com/device/K981582
Methodology: https://510kreport.com/methodology