FDA 510(k)

GCI Surgical Gown

K-Number: K233571 · 2024-08-02

Decision Date2024-08-02

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GCI Surgical Gown is a medical device manufactured by George Courey, Inc.. It received FDA 510(k) clearance on 2024-08-02 under approval number K233571. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GCI Surgical Gown?

GCI Surgical Gown is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by George Courey, Inc.. The 510(k) number is K233571.

When was GCI Surgical Gown approved by the FDA?

GCI Surgical Gown received FDA 510(k) clearance on 2024-08-02, under approval number K233571.

What company makes GCI Surgical Gown?

GCI Surgical Gown is manufactured by George Courey, Inc..

What is the FDA product code for GCI Surgical Gown?

The FDA product code for GCI Surgical Gown is FYA.

Other Devices by George Courey, Inc.

K250321GCI Sterilization Wrappers

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.