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Auto Suture Stainless Steel Sutures

by United States Surgical, A Division of Tyco Healthc

510(k) K872532

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872532 Date5 Aug 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
GAO
Device Class
Class II
Regulation
21 CFR Part 878.4495
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Auto Suture Stainless Steel Sutures are nonabsorbable surgical sutures composed of 316L stainless steel, available in USP sizes 12-0 through 10. They are intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure. The device is supplied as needled or unneedled sutures and is classified under regulation 878.4495 as a Class II medical device.

The sutures are supplied sterile and are intended for single-use in surgical procedures. They are non-absorbable and remain in the body until surgically removed. The device is manufactured by United States Surgical, a division of Tyco Healthcare, and was cleared under FDA 510(k) number K872532 with a substantially equivalent decision. Storage conditions and specific handling instructions are not detailed in the available data.

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Questions

AI-generated answers, 27 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 surgical procedures are these sutures intended for?

    These sutures are designed for abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure. Their nonabsorbable nature provides lasting support in these high-tension or critical areas.

  • How are the sutures supplied and are they sterile?

    They are supplied as either needled or unneedled sutures and come pre-sterilized. Sterility ensures they are ready for immediate use in the operating room without additional processing.

  • Are these sutures reusable or single-use?

    They are strictly single-use devices. Reusing them could compromise structural integrity and sterility, increasing the risk of infection or suture failure.

  • What USP sizes are available and what material are they made of?

    They are made of 316L stainless steel and are available in USP sizes ranging from 12-0 (very fine) to 10 (thick), allowing the surgeon to select the appropriate size for the tissue type and tension required.

  • What is the regulatory classification and clearance route?

    The device is classified as a Class II medical device under regulation 878.4495 and was cleared via the FDA 510(k) premarket notification route, specifically under k-number K872532.