Non-Absorbable Nylon Sutures
by Davis & Geck, Inc. PMA
Active
PMA N83511
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN83511 | Date2 Mar 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Non-Absorbable Sutures Nylon
- Generic Name
- Suture, nonabsorbable, synthetic, polyamide
- PMA Number
- FDA Product Code
- GAR
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5020
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APPR Approved
- PMA Supplement
- S005
Overview
AI-generated summary, 18 Sep 2026
This device is a non-absorbable, synthetic suture made from polyamide (nylon), used for tissue approximation and wound closure in surgical procedures. It provides durable support to tissues over extended periods due to its resistance to degradation by biological processes.
The sutures are supplied in sterile, single-use packaging and are classified under FDA regulation 878.5020 as a Class II device. They are intended for use in general and plastic surgery settings, with various sizes and lengths available to accommodate different clinical applications. Authorised under PMA N83511, these sutures adhere to FDA standards for non-absorbable synthetic sutures.
Other devices from Davis & Geck, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures are these nylon sutures primarily intended for?
These non-absorbable nylon sutures are designed for tissue approximation and wound closure in general and plastic surgery settings. Their durable, synthetic polyamide composition ensures long-term support for tissues, making them suitable for procedures requiring prolonged stability, such as skin closure, ligament repair, or other applications where sustained strength is critical.
Are these sutures meant for single-use only, and if so, how should they be stored?
Yes, these nylon sutures are supplied in sterile, single-use packaging. To maintain sterility, they should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Check the packaging for specific storage instructions, but generally, they should be kept in their original, sealed container until ready for use.
What regulatory pathway was followed for approval, and what does that mean for clinicians?
These sutures were authorized through the FDA’s Premarket Approval (PMA) process under PMA number N83511, meaning they underwent rigorous clinical evaluation to ensure safety and effectiveness. Clinicians can rely on this approval as evidence that the product meets FDA standards for non-absorbable synthetic sutures, specifically for use in general and plastic surgery.
Do these sutures come in multiple sizes or models, and how would I determine the right one for a procedure?
Yes, these sutures are available in various sizes and lengths to accommodate different clinical applications. The exact specifications (e.g., gauge, length, needle type) are typically listed on the packaging or in the product documentation. Selecting the appropriate size depends on the tissue type, wound size, and surgical technique—consult the manufacturer’s guidelines or surgical best practices for guidance.