FDA 510(k)

CiRx (R) Surgical Mask

K-Number: K210256 · 2021-08-19

ApplicantNingbo Shun YE Medical Company, Ltd.

Decision Date2021-08-19

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CiRx (R) Surgical Mask is a medical device manufactured by Ningbo Shun YE Medical Company, Ltd.. It received FDA 510(k) clearance on 2021-08-19 under approval number K210256. 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 CiRx (R) Surgical Mask?

CiRx (R) Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Ningbo Shun YE Medical Company, Ltd.. The 510(k) number is K210256.

When was CiRx (R) Surgical Mask approved by the FDA?

CiRx (R) Surgical Mask received FDA 510(k) clearance on 2021-08-19, under approval number K210256.

What company makes CiRx (R) Surgical Mask?

CiRx (R) Surgical Mask is manufactured by Ningbo Shun YE Medical Company, Ltd..

What is the FDA product code for CiRx (R) Surgical Mask?

The FDA product code for CiRx (R) Surgical Mask is FXX.

Other Devices by Ningbo Shun YE Medical Company, Ltd.

K213786CiRX Single use electrosurgical pencil with non-coated and coated electrode

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

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