Chromic Gut Sterile Absorbable Sutures

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Suture, absorbable, natural

PMA Number

N83433 ↗

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

S009

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See all devices from Davis & Geck, Inc. →

• What types of surgical procedures are these sutures commonly used for?

  These Chromic Gut Sterile Absorbable Sutures are designed for internal tissue approximation and closure, making them suitable for general and plastic surgery procedures. Their absorbable, natural composition and chromic acid treatment provide sustained wound support, which is ideal for applications requiring prolonged tissue stability.

• Are these sutures intended for reuse or are they single-use only?

  The sutures are explicitly labeled for single-use only, adhering to standard surgical aseptic techniques. This ensures patient safety and maintains sterility, as they are supplied in a sterile condition.

• How are these sutures packaged and what sizes are available?

  The sutures are supplied sterile and come in multiple sizes, each identified by a unique reference code. The exact sizes and codes are listed in the provided FEI numbers (e.g., 3015183635, 3010692967), which correspond to different suture gauges and lengths for various clinical applications.

• What regulatory pathway was followed for approval, and what class does this device fall under?

  These sutures were authorized via a Premarket Approval (PMA N83433) and are classified as Class II under FDA regulations (878.4830). The approval process involved submission to the FDA’s advisory committee for General and Plastic Surgery, ensuring compliance with stringent standards for absorbable natural sutures.

• How should these sutures be stored to maintain their sterility and effectiveness?

  While the data does not specify storage conditions explicitly, as a sterile, single-use medical device, these sutures should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Always follow the manufacturer’s guidelines (Davis & Geck, Inc.) for optimal preservation of sterility and performance.