# K981128: Sofsilk Suture

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: May 11, 1998 after 42 days
- Product code: GAP (Suture, Nonabsorbable, Silk)
- Device class: 2
- Regulation: 21 CFR 878.5030
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- Jan 25, 2024 · Class II · Z-1697-2024: One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harm
- Dec 21, 2023 · Class II · Z-0845-2024: 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-1176-2023: 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-2812-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2818-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2817-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2810-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2811-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2814-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2816-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2815-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2813-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2819-2011: Potential for the sterile barrier to be breached compromising the sterility of the product

Source page: https://510kreport.com/device/K981128
Methodology: https://510kreport.com/methodology