Chromic Gut Suture

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Suture, absorbable, natural

PMA Number

N84381 ↗

FDA Product Code

GAL

Device Class

Class II

Regulation

21 CFR Part 878.4830

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S003

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See all devices from Deknatel, Inc. →

• What types of surgical procedures is the Chromic Gut Suture intended for, and why is it preferred in those settings?

  The Chromic Gut Suture is designed for internal tissue approximation and wound closure in surgical procedures, particularly within general and plastic surgery. It is an absorbable, natural suture derived from bovine intestinal submucosa, which means it provides temporary support during the healing process before being gradually absorbed by the body. This makes it ideal for situations where long-term support is unnecessary, reducing the need for suture removal and minimizing tissue trauma.

• Is the Chromic Gut Suture meant for single-use only, and how should it be stored to maintain sterility?

  Yes, the Chromic Gut Suture is supplied in sterile, single-use packaging, ensuring it remains uncontaminated for one-time surgical use. To maintain sterility and integrity before use, it must be stored according to the manufacturer’s guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures, as outlined by Deknatel, Inc.

• What regulatory pathway was followed for the approval of the Chromic Gut Suture, and what does this mean for its use?

  The Chromic Gut Suture received FDA authorization through a Premarket Approval (PMA) application (PMA Number: N84381), which is a rigorous review process for Class II medical devices. This approval indicates that the device has been evaluated for safety and effectiveness by the FDA, allowing it to be legally marketed and used in the United States for its intended surgical applications.

• Are there multiple sizes or models available for the Chromic Gut Suture, and how would a clinician determine the appropriate size for a procedure?

  Yes, the Chromic Gut Suture is available in various sizes and reference codes, as indicated by the multiple FEI numbers and registration numbers listed. The appropriate size depends on the specific surgical needs, such as tissue thickness and the complexity of the wound. Clinicians should refer to the manufacturer’s documentation or surgical guidelines to select the most suitable size for optimal tissue approximation and healing.