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Glycar Staple Strips

by Glycar, Inc.

510(k) K954665

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 NumberK954665 Date14 Feb 1996ClearedStatusActive

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  • Withdrawn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
FTL
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

Glycar Staple Strips are a polymeric surgical mesh device. They are designed to function as surgical staple bolsters for use in various surgical procedures involving the stapling of tissue.

This device is supplied for clinical use and has received FDA 510(k) clearance. It is categorized under the product code FTL for use in general and plastic surgery applications.

Other devices from Glycar, Inc.

Questions

AI-generated answers, 6 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 are Glycar Staple Strips used for?

    Glycar Staple Strips are a polymeric surgical mesh device designed to function as surgical staple bolsters. They are intended to be used in various surgical procedures that involve the stapling of tissue.

  • Which surgical specialties are these staple strips designed for?

    The device is categorized under product code FTL and is intended for use in general and plastic surgery applications.

  • What is the regulatory status of this device?

    Glycar Staple Strips have received FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to a legally marketed predicate device.