Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Non-Sterile Ultrasound Transmission Gels

K-Number: K241789 · 2024-07-24

ApplicantHony Medical Co., Ltd.
Decision Date2024-07-24
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Non-Sterile 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 2024-07-24 under 510(k) number K241789. 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 Non-Sterile Ultrasound Transmission Gels?

Non-Sterile Ultrasound Transmission Gels is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Hony Medical Co., Ltd.. The 510(k) number is K241789.

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

Non-Sterile Ultrasound Transmission Gels received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241789.

Who is the listed applicant for Non-Sterile 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 Non-Sterile Ultrasound Transmission Gels?

The FDA product code for Non-Sterile 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.

K241615Transducer Probe CoverK221278Transducer Probe CoverK221999Ultrasound Transmission Gels

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.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K221999Ultrasound Transmission GelsHony 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.

↑