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Stainless Steel Sutures, Flexon Steel Sutures (Stainless)

by Davis & Geck, Inc.

510(k) K955723

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)SN Traditional NumberK955723 Date27 Feb 1996DecidedStatusActive

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  • Withdrawn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
GAQ
Device Class
Class II
Regulation
21 CFR Part 878.4495
Advisory Committee
General, Plastic Surgery
FDA Decision
SN

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 nonabsorbable, sterile suture composed of stainless steel, classified as a Suture, Nonabsorbable, Steel, Monofilament and Multifilament under FDA nomenclature. It is designed for surgical wound closure, including abdominal, intestinal, hernia, and sternal applications, using USP sizes ranging from 12-0 to 10.

The sutures are supplied in sterile packaging for single-use in clinical settings. They are manufactured from 316L stainless steel, a corrosion-resistant alloy, and are intended for use in general and plastic surgery procedures. Authorized under FDA 510(k) clearance (K955723), these sutures adhere to regulatory standards for medical devices, ensuring compliance with safety and performance requirements.

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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 types of surgical procedures are these stainless steel sutures commonly used for?

    These stainless steel sutures are designed for general and plastic surgery applications, specifically for wound closure in procedures like abdominal, intestinal, hernia repairs, and sternal closures. Their corrosion-resistant 316L stainless steel construction makes them suitable for long-term tissue support in these areas.

  • Are these sutures reusable, or are they intended for single-use only?

    These sutures are supplied in sterile packaging and are intended for single-use in clinical settings. Reuse is not recommended as it could compromise sterility and potentially introduce contamination risks.

  • What sizes are available for these stainless steel sutures, and how do they differ?

    The sutures come in USP sizes ranging from 12-0 to 10, which correspond to varying diameters and thicknesses. Smaller sizes (e.g., 12-0) are typically used for delicate tissues requiring fine precision, while larger sizes (e.g., 10) are suited for thicker tissues or broader wound approximation.

  • How should these sutures be stored to maintain their sterility and performance?

    These sutures are supplied in sterile packaging, so they should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. The packaging should remain unopened until use to preserve sterility and prevent contamination.

  • What material is used in these sutures, and why is it significant for surgical use?

    These sutures are made from 316L stainless steel, a corrosion-resistant alloy known for its strength and biocompatibility. This material is ideal for surgical use because it maintains structural integrity over time, resists degradation in bodily fluids, and minimizes tissue reaction, making it suitable for long-term wound closure.