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FDA 510(k)

EMBRACE GEL

K-Number: K072515 · 2007-09-20

ApplicantOrison Corporation
Decision Date2007-09-20
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMBRACE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Orison Corporation. It received FDA 510(k) clearance on 2007-09-20 under 510(k) number K072515. 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 EMBRACE GEL?

EMBRACE GEL is a medical device that received FDA 510(k) clearance on 2007-09-20. The listed applicant is Orison Corporation. The 510(k) number is K072515.

When did EMBRACE GEL receive FDA 510(k) clearance?

EMBRACE GEL received FDA 510(k) clearance on 2007-09-20, under 510(k) number K072515.

Who is the listed applicant for EMBRACE GEL?

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

What is the FDA product code for EMBRACE GEL?

The FDA product code for EMBRACE GEL is MUI.

Related Clinical Trials

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.

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Other records listing Orison 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.

K070477ORISON EMBRACE SYSTEM

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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