# K930825: Suture Nonabsorbable-Nylon,Silk,Polyester,Stainles

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Specialties, Inc.
- Decided: Jan 7, 1994 after 324 days
- Product code: GAP (Suture, Nonabsorbable, Silk)
- Device class: 2
- Regulation: 21 CFR 878.5030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K131224: Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless Tissue-Closure (2013), 2 descendants of its own
- K233355: Cypris eXact Suturing System (2024), 0 descendants of its own
- K211178: DURAMESH Mesh Suture (2022), 0 descendants of its own
- K052900: Quill Nonabsorbable Nylon Barbed Suture (2005), 0 descendants of its own

## Recalls of this device
- Sep 9, 2008 · Not classified · Z-0034-2009: mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture

Source page: https://510kreport.com/device/K930825
Methodology: https://510kreport.com/methodology