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Nonabsorbable Surg. Sutures, Nylon

by Deknatel, Inc. PMA

Active United States

PMA N85060

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN85060 Date31 Dec 1980ApprovedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

PMA

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.