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Advance Suture Nonabsorbable Dacron Suture

by Advance Suture, Inc.

510(k) K903175

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 NumberK903175 Date26 Jul 1991ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
GAS
Device Class
Class II
Regulation
21 CFR Part 878.5000
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Advance Suture Nonabsorbable Dacron Suture is a Suture, Nonabsorbable, Synthetic, Polyester device, classified under FDA regulation 878.5000. It consists of a multifilament, nonabsorbable, sterile thread made from high molecular weight, long-chain, linear polyesters containing aromatic rings. This suture is designed for soft tissue approximation in surgical procedures, providing durable closure due to its synthetic polyester composition.

Supplied as a sterile, single-use product, this suture is intended for use in general and plastic surgery settings. It is manufactured under FDA 510(k) clearance (K903175) and falls under Device Class II. The product is packaged for surgical use and adheres to regulatory standards for nonabsorbable sutures, ensuring reliability for prolonged tissue support. No MRI safety or reusable specifications are noted in the data.

Other devices from Advance Suture, Inc.

Questions

AI-generated answers, 1 Oct 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 Advance Suture Nonabsorbable Dacron Suture used for?

    This suture is designed specifically for soft tissue approximation in surgical procedures, providing durable closure due to its synthetic polyester composition. Its multifilament structure makes it ideal for applications requiring prolonged tissue support, such as in general and plastic surgery settings.

  • Is the Advance Suture Nonabsorbable Dacron Suture sterile and single-use?

    Yes, the Advance Suture Nonabsorbable Dacron Suture is supplied as a sterile, single-use product. This ensures safety and reliability for surgical use, as it is intended to be used only once per patient to maintain sterility and reduce infection risks.

  • What materials is the Advance Suture Nonabsorbable Dacron Suture made from?

    The suture is made from high molecular weight, long-chain, linear polyesters containing aromatic rings. This composition gives it its nonabsorbable properties, ensuring it remains intact in the body for extended periods to support tissue healing.

  • What sizes or models are available for the Advance Suture Nonabsorbable Dacron Suture?

    The device is available in multiple sizes and models, as indicated by the listed FEI numbers (e.g., 3005747797, 3016851379, etc.). These variations allow clinicians to select the appropriate suture size and type for specific surgical needs, ensuring optimal performance for different tissue types and procedures.

  • How should the Advance Suture Nonabsorbable Dacron Suture be stored?

    While the provided data does not specify storage conditions explicitly, standard practice for sterile, single-use sutures typically involves storing them in a clean, dry environment, protected from direct sunlight and extreme temperatures. Always follow the manufacturer’s instructions on the packaging for precise storage guidelines to maintain sterility and integrity.