Catgut Suture

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

Generic name

Suture, absorbable, natural

FDA applicant

ETHICON, Inc.

PMA number

N8536 ↗

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

S019

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  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B413

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  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B409

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• Stratafix SXPN1B403

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  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B404

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  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B412

  Class II

  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

See all devices from Ethicon Inc. →

• What types of surgical procedures is the Catgut Suture primarily intended for, and why is it a good choice for those applications?

  The Catgut Suture is designed for general surgical applications, including plastic surgery, where temporary tissue support is needed for soft tissue approximation and wound closure. It is an absorbable, natural suture material, meaning it gradually dissolves in the body over time, eliminating the need for suture removal. This makes it particularly useful in procedures where long-term support isn’t required, reducing patient discomfort and follow-up visits.

• Is the Catgut Suture reusable, or is it intended for single-use only? How does this affect its handling in the operating room?

  The Catgut Suture is explicitly supplied in a sterile form for single-use only, as stated in the device description. This means each package is intended for one surgical procedure and should not be reused, even if it appears unused. Sterility is critical for surgical applications, so single-use ensures patient safety and reduces the risk of infection. Proper disposal after use is essential to maintain sterile conditions in the OR.

• What sizes and reference codes are available for the Catgut Suture, and how can I determine which one is best for my procedure?

  The Catgut Suture comes in multiple sizes and reference codes, as listed in the OpenFDA database (e.g., 3015183635, 3010692967, etc.). These variations allow compatibility with different surgical needs, such as tissue thickness or suture tension requirements. To select the appropriate size, consult surgical guidelines or product literature provided by Ethicon, which typically recommend specific gauges (e.g., 2-0, 3-0) based on the procedure and tissue type. Always verify the packaging for the correct reference code before use.

• How should the Catgut Suture be stored to maintain its sterility and effectiveness before use?

  Since the Catgut Suture is sterile and intended for single-use, it must be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Check the expiration date on the package, as absorbable sutures may degrade over time if not stored properly. Once opened, the suture should be used immediately in a sterile field.

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

  The Catgut Suture received Premarket Approval (PMA) under FDA number N8536, which is a rigorous review process for higher-risk medical devices. This approval indicates that the device has been evaluated for safety and effectiveness by the FDA, ensuring it meets regulatory standards for its intended use in soft tissue approximation and wound closure. Clinicians can rely on this approval when selecting the suture for procedures, though they should always follow facility protocols and manufacturer instructions for proper use.