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FDA 510(k)

Ultrasound Transmission Gels

K-Number: K221999 · 2022-08-30

ApplicantHony Medical Co., Ltd.
Decision Date2022-08-30
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultrasound Transmission Gels is the device name listed in this FDA 510(k) record. The listed applicant is Hony Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K221999. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasound Transmission Gels?

Ultrasound Transmission Gels is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Hony Medical Co., Ltd.. The 510(k) number is K221999.

When did Ultrasound Transmission Gels receive FDA 510(k) clearance?

Ultrasound Transmission Gels received FDA 510(k) clearance on 2022-08-30, under 510(k) number K221999.

Who is the listed applicant for Ultrasound Transmission Gels?

The FDA 510(k) record lists Hony Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasound Transmission Gels?

The FDA product code for Ultrasound Transmission Gels is MUI.

Other records listing Hony Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241789Non-Sterile Ultrasound Transmission GelsK241615Transducer Probe CoverK221278Transducer Probe Cover

Related Devices (Code: MUI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd.K252337EdgeFlow Gel PadEdgecare, Inc.K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K211691Ultrast GelUltrast, Inc.

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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