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FDA 510(k)

Procedure Mask

K-Number: K220377 · 2022-06-24

ApplicantLittle Rapids Corporation
Decision Date2022-06-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Procedure Mask is a medical device manufactured by Little Rapids Corporation. It received FDA 510(k) clearance on 2022-06-24 under approval number K220377. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Procedure Mask?

Procedure Mask is a medical device that received FDA 510(k) clearance on 2022-06-24. It is manufactured by Little Rapids Corporation. The 510(k) number is K220377.

When was Procedure Mask approved by the FDA?

Procedure Mask received FDA 510(k) clearance on 2022-06-24, under approval number K220377.

What company makes Procedure Mask?

Procedure Mask is manufactured by Little Rapids Corporation.

What is the FDA product code for Procedure Mask?

The FDA product code for Procedure Mask is FXX.

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

Official Source

View on FDA Database →

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

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