Silk Surgical Sutures

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

Trade Name

Sutures

Generic Name

Suture, nonabsorbable, silk

PMA Number

N85143 ↗

FDA Product Code

GAP

Device Class

Class II

Regulation

21 CFR Part 878.5030

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S001

• Dacron R Surgical Sutures

  Class II

  FDA 510(k) K904263 Active Cleared 16 Oct 1990

• Ear Knives

  Class I

  FDA 510(k) K840764 Active Cleared 21 May 1984

• Corneal Scleral Lance

  Class I

  FDA 510(k) K840855 Active Cleared 9 May 1984

• Coated Suture Needle

  Class I

  FDA 510(k) K863595 Active Cleared 24 Oct 1986

• Surgical Knife

  Class I

  FDA 510(k) K861947 Active Cleared 6 Jun 1986

• Anterior Capsulectomy Cystitome

  Class I

  FDA 510(k) K840659 Active Cleared 16 Mar 1984

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• Are Silk Surgical Sutures reusable or intended for single-use only?

  Silk Surgical Sutures are supplied in sterile, single-use packaging, meaning each package is designed for one-time use only. Reuse is not recommended as it could compromise sterility and patient safety.

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

  These sutures are specifically designed for use in general and plastic surgery procedures, where they provide tissue approximation and ligation in soft tissues. They are intended to support wound closure and healing during these types of surgeries.

• How do I determine the correct size and length of Silk Surgical Sutures for a procedure?

  The sutures come in multiple sizes and lengths, each identified by unique registration numbers (e.g., 3038718579, 1221051). The correct size and length depend on the specific surgical needs, such as tissue thickness and the type of closure required. Consult the product packaging or manufacturer documentation for detailed size and length specifications.

• What regulatory pathway does Silk Surgical Sutures follow, and what does this mean for purchasing?

  Silk Surgical Sutures hold an FDA Premarket Approval (PMA) under product code GAP with PMA number N85143 and supplement S001. This means the device has undergone rigorous review by the FDA to ensure safety and effectiveness, providing assurance of quality and compliance with regulatory standards for Class II medical devices.

• How should Silk Surgical Sutures be stored to maintain their sterility and usability?

  Since these sutures are supplied in sterile packaging, they should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and contaminants. Always follow the manufacturer’s storage instructions on the packaging to preserve sterility and ensure proper functionality.