Chromic and Plain Gut Sutures

No FDA recalls on record, checked 22 Oct 2026.

Full name

Revised Labeling for Chromic and Plain Gut Sutures

510(k) Number

K926586 ↗

FDA Product Code

GAL

Device Class

Class II

Regulation

21 CFR Part 878.4830

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What are chromic and plain gut sutures used for?

  Chromic and plain gut sutures are absorbable, natural sutures derived from animal intestines. They are designed for temporary tissue support during the healing process in surgical procedures, particularly in general and plastic surgery. Chromic gut is treated with chromic acid to slow absorption, making it suitable for prolonged wound closure, while plain gut absorbs more rapidly, ideal for shorter healing periods.

• How are these sutures supplied and what is their sterility status?

  The chromic and plain gut sutures are supplied in sterile, single-use packaging specifically designed for surgical settings. This ensures sterility and integrity are maintained until use, preventing contamination and ensuring patient safety.

• Are these sutures single-use or reusable?

  These sutures are intended for single-use only. The sterile packaging is designed to maintain sterility for one surgical procedure, ensuring compliance with medical best practices and reducing the risk of infection.

• What sizes and models are available for these sutures?

  The chromic and plain gut sutures come in various sizes and lengths, as indicated by the multiple registration numbers (e.g., 3015183635, 3010692967, etc.). These variations allow clinicians to select the appropriate suture based on the specific surgical requirements and tissue type.

• How should these sutures be stored to maintain their integrity?

  To maintain sterility and integrity, these sutures must be stored under controlled conditions as specified by the manufacturer. This typically includes keeping them in a clean, dry environment, away from direct sunlight, and within the expiration date to ensure optimal performance and safety.