# K930739: Sutures Polyprop., Polyetheline, Nylon & Silk

- Pathway: 510(k) (Traditional)
- Applicant: Deknatel, Inc.
- Decided: Jul 26, 1994 after 529 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K192490: Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch (2020), 1 descendant of its own
- K241111: AMT Suture Passer (2024), 0 descendants of its own

## Recalls of this device
- Jun 6, 2007 · Not classified · Z-1018-2007: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

Source page: https://510kreport.com/device/K930739
Methodology: https://510kreport.com/methodology
