FDA 510(k)

Surgical Gown

K-Number: K213844 · 2023-02-16

ApplicantBayteks Teknik Tekstil San. VE Tic. A.S.

Decision Date2023-02-16

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surgical Gown is a medical device manufactured by Bayteks Teknik Tekstil San. VE Tic. A.S.. It received FDA 510(k) clearance on 2023-02-16 under approval number K213844. 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 Surgical Gown?

Surgical Gown is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Bayteks Teknik Tekstil San. VE Tic. A.S.. The 510(k) number is K213844.

When was Surgical Gown approved by the FDA?

Surgical Gown received FDA 510(k) clearance on 2023-02-16, under approval number K213844.

What company makes Surgical Gown?

Surgical Gown is manufactured by Bayteks Teknik Tekstil San. VE Tic. A.S..

What is the FDA product code for Surgical Gown?

The FDA product code for Surgical Gown is FYA.

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.