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FDA 510(k)

Safergel Sterile Ultrasound Gel

K-Number: K190591 · 2019-10-04

ApplicantSafersonic Us, Inc.
Decision Date2019-10-04
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Safergel Sterile Ultrasound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Safersonic Us, Inc.. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190591. 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 Safergel Sterile Ultrasound Gel?

Safergel Sterile Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Safersonic Us, Inc.. The 510(k) number is K190591.

When did Safergel Sterile Ultrasound Gel receive FDA 510(k) clearance?

Safergel Sterile Ultrasound Gel received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190591.

Who is the listed applicant for Safergel Sterile Ultrasound Gel?

The FDA 510(k) record lists Safersonic Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safergel Sterile Ultrasound Gel?

The FDA product code for Safergel Sterile Ultrasound 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.

NCT07647757Neurolyser XR for the Treatment of SacroiliitisNOT_YET_RECRUITING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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