Nylon Nonabsorbable Surgical Sutures USP
by R. K. Medical L. L. C. 510(k)
Active
510(k) K960327
Overview
This device is a nonabsorbable synthetic suture made from polyamide (nylon), classified under FDA regulation 878.5020. It is designed for soft tissue approximation and ligation, providing mechanical closure and maintaining tensile strength during the healing process. Available in monofilament or braided forms, it may be coated (silicone or wax) or uncoated, and can be dyed (black or blue) or undyed to enhance visibility during surgical procedures.
Nylon nonabsorbable sutures are intended for use in general, plastic, cardiovascular, ophthalmic, and neurological surgeries. Supplied sterile and single-use, they are regulated under FDA 510(k) clearance (K960327) with a traditional review process. The device adheres to USP XXIII standards for performance verification and is distributed in various sizes and configurations as listed in the registration numbers. No MRI safety information is specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK960327 | Date4 Mar 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Nylon Noabsorbable Surgical Sutures Usp
- 510(k) Number
- FDA Product Code
- GAR
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5020
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SN
Other devices from R. K. Medical L. L. C.
Questions
What is the primary use of these nylon nonabsorbable sutures?
These nylon sutures are designed for soft tissue approximation and ligation, providing mechanical closure and maintaining tensile strength during the healing process. They are suitable for general, plastic, cardiovascular, ophthalmic, and neurological surgeries, ensuring durable wound closure where long-term support is required.
Are these sutures single-use or reusable?
These nylon sutures are supplied sterile and intended for single-use only. Reuse is not recommended as it may compromise sterility and compromise patient safety, particularly in surgical settings where infection control is critical.
What forms and coatings are available for these sutures?
The sutures are available in monofilament or braided forms and can be either coated (with silicone or wax) or uncoated. Coatings reduce tissue drag and improve handling, while the braided form offers enhanced knot security compared to monofilament.
How are these sutures sterilized and stored?
These sutures are supplied sterile, meaning they undergo a validated sterilization process (likely gamma irradiation or ethylene oxide) to ensure safety for surgical use. Storage should follow manufacturer guidelines—typically in a clean, dry environment, protected from direct sunlight and extreme temperatures, to preserve sterility and integrity until use.
What sizes and configurations are available for these nylon sutures?
These sutures are available in a wide range of sizes and configurations, including various diameters (measured in metric units) and lengths, as well as dyed (black or blue) or undyed variants for enhanced visibility. The exact specifications are listed under registration numbers like 3038718579, 1221051, and others in the FDA database, ensuring compatibility with diverse surgical needs.