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GCI Surgical Gown

by George Courey, Inc.

510(k) K233571

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 NumberK233571 Date2 Aug 2024ClearedStatusActive

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  • Withdrawn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
FYA
Device Class
Class II
Regulation
21 CFR Part 878.4040
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.

The GCI Surgical Gown is a reusable surgical textile designed to provide protection, comfort, and durability during medical procedures. It is intended for use in general and plastic surgery settings to maintain infection control standards.

The device is supplied as a reusable product and is MRI safe. It is authorized under FDA 510(k) clearance with number K233571, received on 2024-08-02. The gown is manufactured by George Courey, Inc. and is available in various levels of protection (L2, L3, and L4).

Other devices from George Courey, Inc.

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 is the GCI Surgical Gown used for?

    The GCI Surgical Gown is a reusable surgical textile designed for use in general and plastic surgery settings to maintain infection control standards while providing protection, comfort, and durability during medical procedures.

  • Is the GCI Surgical Goon reusable or single-use?

    The GCI Surgical Gown is supplied as a reusable product, making it suitable for multiple uses in surgical settings while maintaining infection control standards.

  • What protection levels are available for the GCI Surgical Gown?

    The GCI Surgical Gown is available in various levels of protection including L2, L3, and L4, allowing healthcare providers to select the appropriate level of barrier protection for different surgical procedures.

  • What is the regulatory status of the GCI Surgical Gown?

    The GCI Surgical Gown is authorized under FDA 510(k) clearance with number K233571, received on 2024-08-02, and is classified as substantially equivalent to predicate devices.