Dexon Polyglycolic Acid Suture

No FDA recalls on record, checked 22 Oct 2026.

Full name

Dexon

Generic Name

Suture, absorbable, synthetic, polyglycolic acid

PMA Number

N16881 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S001

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• What types of surgical procedures is the Dexon Polyglycolic Acid Suture intended for, and why is it a good choice for those procedures?

  The Dexon Polyglycolic Acid Suture is designed for use in general and plastic surgery procedures. It provides temporary tissue support during the healing process, making it suitable for applications where temporary reinforcement of tissues is needed, such as wound closure or internal suturing. Its absorbable nature ensures it dissolves over time, reducing the need for suture removal and minimizing tissue reaction.

• Is the Dexon Polyglycolic Acid Suture reusable, or is it meant for single-use only? How should it be handled to maintain sterility?

  The Dexon Polyglycolic Acid Suture is supplied in sterile, single-use packaging, meaning each package is intended for one surgical procedure only. To maintain sterility, it must be handled using aseptic techniques, ensuring the sterile barrier remains intact until use. This prevents contamination and ensures patient safety.

• What regulatory pathway was followed for the approval of the Dexon Polyglycolic Acid Suture, and what does this mean for its use in clinical settings?

  The Dexon Polyglycolic Acid Suture received FDA Premarket Approval (PMA) under the classification of a Class II medical device, regulated under regulation number 878.4493. This approval indicates that the device has undergone rigorous evaluation to ensure its safety and effectiveness for its intended use in surgical settings, providing clinicians with confidence in its reliability for general and plastic surgery procedures.

• Are there different sizes available for the Dexon Polyglycolic Acid Suture, and how might this affect its selection for a specific procedure?

  Yes, the Dexon Polyglycolic Acid Suture is available in various sizes, though the exact sizes are not specified in the provided data. The choice of size would depend on the specific surgical requirements, such as tissue thickness and the need for precise suturing. Larger sizes may be used for thicker tissues, while smaller sizes could be better suited for delicate or finer work, ensuring optimal tissue support during healing.