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Stryker Suture Tape

by Stryker

510(k) K150584

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 NumberK150584 Date13 Aug 2015ClearedStatusActive

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  • Withdrawn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
GAT
Device class
Class II
Regulation
21 CFR Part 878.5000
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Stryker Suture Tape is a soft‑tissue fixation device classified as a suture tape. It is designed to provide a broad, flat profile for enhanced tissue holding compared with traditional round sutures, and is offered in multiple widths, lengths, and color patterns for improved visibility during surgery.

The product was cleared through the FDA 510(k) pathway (traditional clearance) on 13 August 2015, with a decision of substantially equivalent to a predicate device. It is supplied by Stryker and identified by K‑number K150584 and product code GAT. The device is marketed for use in general and plastic surgery procedures, and is available in configurations with or without needles.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Questions

AI-generated answers, 21 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 Stryker Suture Tape used for?

    The Stryker Suture Tape is a soft-tissue fixation device designed to provide a broad, flat profile for enhanced tissue holding compared to traditional round sutures, and is marketed for use in general and plastic surgery procedures.

  • How is the Stryker Suture Tape supplied and configured?

    The device is supplied by Stryker and offered in multiple widths, lengths, and color patterns for improved visibility during surgery, and is available in configurations with or without needles to suit different surgical needs.

  • What regulatory pathway was used for the Stryker Suture Tape?

    The Stryker Suture Tape received FDA 510(k) clearance through the traditional pathway on 13 August 2015, with a determination of substantially equivalent to a predicate device under product code GAT and K-number K150584.