Nonabsorbable Surg. Sutures, Nylon
by Deknatel, Inc. PMA
Active
PMA N85060
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN85060 | Date31 Dec 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
- S001
Overview
AI-generated summary, 18 Sep 2026
This device is a suture, nonabsorbable, synthetic, polyamide, classified under FDA regulation 878.5020. It is designed for use in general and plastic surgery to approximate and ligate soft tissues during surgical procedures. The sutures are made from nylon, a durable synthetic material that maintains tensile strength over time, ensuring reliable wound closure and tissue support.
The sutures are supplied in sterile, single-use packaging and are intended for reusable or single-patient use depending on clinical practice. They are not MRI-safe and must be handled with sterile technique. Available in multiple sizes and lengths, they are stored under controlled conditions to preserve sterility and integrity. Authorized under FDA Premarket Approval (PMA N85060), these sutures comply with regulatory standards for nonabsorbable surgical sutures.
Other devices from Deknatel, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures are these nylon sutures primarily used for?
These nonabsorbable nylon sutures are designed for general and plastic surgery applications, where they are used to approximate (close) and ligate (tie off) soft tissues during surgical procedures. Their durable synthetic polyamide material ensures reliable wound closure and tissue support over time.
Are these sutures intended for single-use or can they be reused?
The sutures are supplied in sterile, single-use packaging, but their clinical use—whether single-patient or reusable—depends on the facility’s established protocols and infection control practices. The manufacturer does not specify reuse, so adherence to sterile technique is critical if reused.
What sizes and models are available for these nylon sutures?
The sutures come in multiple sizes and lengths, though exact dimensions are not detailed in the provided data. They are categorized under FDA product code GAR for nonabsorbable sutures, indicating a range of gauges and lengths tailored for general and plastic surgery needs.
How should these sutures be stored to maintain sterility and integrity?
The sutures must be stored under controlled conditions to preserve their sterility and structural integrity. Since they are supplied in sterile packaging, they should remain unopened until use and protected from contamination, moisture, or extreme temperatures.
Can these sutures be used in MRI procedures, and what precautions should be taken?
These nylon sutures are not MRI-safe, meaning they should not be used in patients who will undergo MRI scans. If MRI is required post-surgery, alternative non-MRI-compatible sutures should be considered, or the patient should be monitored for potential artifacts or heating during imaging.