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Nylon Suture, Nonabsorbable, Synthetic, Polyamide

by Trading Consultants and Distributors Intl., Inc.

510(k) K993998

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993998 Date4 Feb 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Nylon
510(k) Number
FDA Product Code
GAR
Device Class
Class II
Regulation
21 CFR Part 878.5020
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 as a Class II medical device under FDA regulation 878.5020. It is a monofilament or multifilament suture composed of polyamide (nylon), designed for use in soft tissue approximation and ligation during surgical procedures. The suture is intended for general and plastic surgery applications, providing durable closure with minimal tissue reactivity.

Nylon sutures are supplied in sterile, single-use packaging and are compatible with standard surgical settings, including MRI environments, as they are non-metallic. They are available in various sizes and lengths, as indicated by the listed FEI numbers, and must be stored according to manufacturer instructions to maintain sterility. This product holds an FDA 510(k) clearance (K993998) under the Traditional 510(k) review pathway, with a decision date of February 4, 2000.

Other devices from Trading Consultants and Distributors Intl., Inc.

Questions

AI-generated answers, 19 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 is the composition and intended use of this nylon suture?

    This is a nonabsorbable synthetic suture made of polyamide (nylon), designed for soft tissue approximation and ligation during general and plastic surgery procedures.

  • How is the nylon suture supplied and what are its packaging requirements?

    The suture is supplied in sterile, single-use packaging to maintain sterility and prevent contamination during surgical procedures.

  • Is this nylon suture compatible with MRI environments?

    Yes, the suture is compatible with MRI environments as it is non-metallic, making it safe for use in patients undergoing magnetic resonance imaging.

  • What regulatory status does this nylon suture hold?

    The suture has FDA 510(k) clearance (K993998) under the Traditional 510(k) review pathway, with a decision date of February 4, 2000.

  • What sizes and lengths are available for this nylon suture?

    The suture is available in various sizes and lengths, as indicated by the multiple FEI numbers listed in the device specifications.