# K972566: Dexon Violet

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Aug 14, 1997 after 36 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
Longest line of descent: 1 generation back to K900198 (1990). 2 ancestors in all.
27 later devices descend from it; 7 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951352: Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture, Davis & Geck, Inc. (1995) Summary page 1.
- K900198: Dexon II Absorbable Surgical Suture, U.S.P., American Cyanamid Co. (1990) Summary page 1.
- (no number) Vicryl Braided (Polyglactin 910) Suture: named in the summary without a submission number
- (no number) Polysorb Violet Suture: named in the summary without a submission number

## Most influential descendants
- 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
- K191268: Force Fiber Suture (2019), 2 descendants of its own

## Indications for use
The Polyglycolic Acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Source page: https://510kreport.com/device/K972566
Methodology: https://510kreport.com/methodology