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FDA 510(k)

Sterile and Non-Sterile Ultrasound Gels

K-Number: K232957 · 2023-12-15

ApplicantJianerkang Medical Co., Ltd.
Decision Date2023-12-15
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sterile and Non-Sterile Ultrasound Gels is the device name listed in this FDA 510(k) record. The listed applicant is Jianerkang Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232957. 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 Sterile and Non-Sterile Ultrasound Gels?

Sterile and Non-Sterile Ultrasound Gels is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Jianerkang Medical Co., Ltd.. The 510(k) number is K232957.

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

Sterile and Non-Sterile Ultrasound Gels received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232957.

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

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

What is the FDA product code for Sterile and Non-Sterile Ultrasound Gels?

The FDA product code for Sterile and Non-Sterile Ultrasound Gels is MUI.

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.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.

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