Dexon Violet

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K972566 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Davis & Geck, Inc. →

• What is Dexon Violet suture made of?

  Dexon Violet is a synthetic absorbable suture made of polyglycolic acid. It is designed to be sterile, inert, noncollagenous, nonantigenic, and nonpyrogenic for various surgical procedures.

• In what forms is Dexon Violet suture available?

  The suture is available in various lengths, diameters, and quantities, with and without surgical needles to accommodate different surgical needs and preferences.

• What is the regulatory classification of Dexon Violet suture?

  Dexon Violet is regulated under FDA 510(k) clearance with product code GAM and is classified as a Class II device for general and plastic surgery use.

• Is Dexon Violet suture single-use or reusable?

  The device data does not specify whether Dexon Violet suture is single-use or reusable. For proper usage and safety information, please refer to the manufacturer's instructions or consult with a healthcare professional.