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Sutrasilk Silk Suture

FDA 510(k)

Class II (US FDA 510(k))

510(k) K994177

by Visionary Medical Supplies, Inc.

Identifiers

510(k) Number
K994177 FDA 510(k)
FDA Product Code
GAP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5030 FDA 510(k)
Regulation Number
878.5030 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sutrasilk Silk Suture is a nonabsorbable, braided silk suture designed for surgical applications. It is classified as a suture material and is intended for use in tissue approximation and ligation, providing strength and stability during wound closure. The suture is dyed black to improve visibility during procedures, enhancing precision and control for the surgeon.

This suture is supplied in single-use, sterile packaging and is available in various sizes, including 8-0, 7-0, 6-0, and 4-0, with standard lengths of 16 inches (40 cm). It is intended for use in ophthalmic surgeries such as cataract, corneal, orbit, and oculoplasty procedures. The device holds an FDA 510(k) clearance (K994177) under the product code GAP, classified as Class II with special controls, and is regulated under 878.5030.

Frequently asked questions

What is the Sutrasilk Silk Suture used for in surgical procedures?

The Sutrasilk Silk Suture is designed for tissue approximation and ligation during surgical procedures. Its primary use is in ophthalmic surgeries, including cataract, corneal, orbit, and oculoplasty procedures. The black dye enhances visibility, allowing surgeons to achieve greater precision and control when closing wounds or securing tissues.

How is the Sutrasilk Silk Suture supplied, and is it sterile?

The Sutrasilk Silk Suture is supplied in single-use, sterile packaging. This ensures that each package is uncontaminated and ready for immediate use in surgical settings, reducing the risk of infection and maintaining sterility throughout the procedure.

Is the Sutrasilk Silk Suture reusable, or is it intended for single-use only?

The Sutrasilk Silk Suture is explicitly intended for single-use only. This design choice aligns with best practices in surgical settings to prevent cross-contamination and ensure patient safety. Reusing sutures can introduce risks of infection or material degradation.

What sizes and lengths are available for the Sutrasilk Silk Suture?

The Sutrasilk Silk Suture is available in multiple sizes, including 8-0, 7-0, 6-0, and 4-0. Each size is supplied with a standard length of 16 inches (40 cm), providing flexibility for various ophthalmic procedures and tissue types.

How should the Sutrasilk Silk Suture be stored to maintain its integrity?

The Sutrasilk Silk Suture should be stored in its original, unopened sterile packaging to preserve sterility and prevent contamination. It should be kept in a clean, dry environment, away from direct sunlight or extreme temperatures, as these conditions can degrade the suture material over time.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SUTRASILK (US) | VisionaryMedical, K994177 FDA 510 (k) - SUTRASILK SILK SUTURE, VISIONARY MEDICAL SUPPLIES INC VS84081 Sutrasilk

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Visionary Medical Supplies, Inc.

Sources (1)

  • FDA 510(k) K994177 24 fields · synced Oct 1, 2026