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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 a medical device manufactured by Hony Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under approval 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. It is manufactured by Hony Medical Co., Ltd.. The 510(k) number is K221999.

When was Ultrasound Transmission Gels approved by the FDA?

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

What company makes Ultrasound Transmission Gels?

Ultrasound Transmission Gels is manufactured by Hony Medical Co., Ltd..

What is the FDA product code for Ultrasound Transmission Gels?

The FDA product code for Ultrasound Transmission Gels is MUI.

Related Clinical Trials

NCT07216274 Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer COMPLETED NCT07498153 Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting COMPLETED

Other Devices by Hony Medical Co., Ltd.

K221278Transducer Probe Cover K241789Non-Sterile Ultrasound Transmission Gels K241615Transducer Probe Cover

Related Devices (Code: MUI)

K151070Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical K163050Advance Medical Designs, Inc. Sterile Ultrasound GelAdvance Medical Designs, Inc. K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. K163027Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc. K163026Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. K163024Ultra/Phonic Conductivity GelPharmaceutical Innovations, 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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