# K951352: Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Jun 5, 1995 after 73 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 4 cite it directly.
0 of 31 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
- K972566: Dexon Violet (1997), 27 descendants of its own
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture (1999), 14 descendants of its own
- K181774: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture (2018), 10 descendants of its own
- K100461: PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut (2010), 5 descendants of its own
- K230311: HyperSuture (2023), 4 descendants of its own

Source page: https://510kreport.com/device/K951352
Methodology: https://510kreport.com/methodology