Dacron R Surgical Sutures

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

510(k) Number

K904263 ↗

FDA Product Code

GAS

Device Class

Class II

Regulation

21 CFR Part 878.5000

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 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

• Ophthalmic Knife

  Class I

  FDA 510(k) K822112 Active Cleared 10 Aug 1982

See all devices from Sharpoint, Inc. →

• Are these sutures reusable or intended for single-use only, and how should they be handled to maintain sterility?

  The Dacron R Surgical Sutures are supplied in sterile, single-use packaging, meaning each package is intended for one surgical procedure only. To maintain sterility, ensure the packaging remains unopened and intact until immediately before use. Once opened, use the sutures promptly and avoid contamination by handling only the sterile portions of the packaging.

• What types of surgical procedures are these sutures commonly used for, and why are they preferred in those settings?

  These sutures are designed for use in general and plastic surgery settings, where durable tissue approximation and long-term wound stability are required. As nonabsorbable, synthetic, polyester sutures, they provide sustained strength during the healing process, making them ideal for applications where prolonged support is necessary, such as in high-tension areas or delayed healing scenarios.

• What needle sizes and suture lengths are available for the Dacron R Surgical Sutures, and how does this variety benefit clinicians?

  The Dacron R Sutures come in multiple needle sizes and suture lengths, as indicated by the extensive list of FEI numbers in the regulatory data. This variety allows clinicians to select the appropriate size and length for specific anatomical needs, ensuring precision in tissue handling and closure. For example, finer needles may be used for delicate tissues, while longer lengths accommodate larger wounds or deeper suturing.

• How should these sutures be stored to preserve their integrity and performance?

  These sutures should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Since they are supplied in sterile packaging, it’s important to keep them sealed until use to prevent contamination. Proper storage ensures the sutures retain their strength and sterility, maintaining their intended performance for surgical applications.

• What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians using the product?

  The Dacron R Surgical Sutures received FDA clearance under the Traditional 510(k) pathway, specifically classified as substantially equivalent (SESE) to a predicate device. This means the FDA determined they have the same intended use and technological characteristics as a previously cleared device, ensuring they meet established safety and effectiveness standards. Clinicians can rely on this clearance as evidence of the product’s regulatory scrutiny and compliance with surgical suture requirements.