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FDA 510(k)

DYNAREX ULTRASOUND GEL

K-Number: K102637 · 2011-02-16

ApplicantDynarex Corporation
Decision Date2011-02-16
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DYNAREX ULTRASOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corporation. It received FDA 510(k) clearance on 2011-02-16 under 510(k) number K102637. 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 DYNAREX ULTRASOUND GEL?

DYNAREX ULTRASOUND GEL is a medical device that received FDA 510(k) clearance on 2011-02-16. The listed applicant is Dynarex Corporation. The 510(k) number is K102637.

When did DYNAREX ULTRASOUND GEL receive FDA 510(k) clearance?

DYNAREX ULTRASOUND GEL received FDA 510(k) clearance on 2011-02-16, under 510(k) number K102637.

Who is the listed applicant for DYNAREX ULTRASOUND GEL?

The FDA 510(k) record lists Dynarex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNAREX ULTRASOUND GEL?

The FDA product code for DYNAREX ULTRASOUND GEL is MUI.

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Other records listing Dynarex Corporation 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.

K172266Dynarex Three-Way StopcockK152970Dynarex Xeroform Petrolatum DressingK103086DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRICK092488DYNAREX STERILE LUBRICATING JELLYK082863DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)K081569DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS

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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.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.

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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