FDA 510(k)

Maxima Surgical Gown

K-Number: K201351 · 2022-03-11

Decision Date2022-03-11

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Maxima Surgical Gown is a medical device manufactured by Elevate Textiles. It received FDA 510(k) clearance on 2022-03-11 under approval number K201351. 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 Maxima Surgical Gown?

Maxima Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Elevate Textiles. The 510(k) number is K201351.

When was Maxima Surgical Gown approved by the FDA?

Maxima Surgical Gown received FDA 510(k) clearance on 2022-03-11, under approval number K201351.

What company makes Maxima Surgical Gown?

Maxima Surgical Gown is manufactured by Elevate Textiles.

What is the FDA product code for Maxima Surgical Gown?

The FDA product code for Maxima 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.