FDA 510(k)

Safergel Sterile Ultrasound Gel

K-Number: K190591 · 2019-10-04

Decision Date2019-10-04

Product CodeMUI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Safergel Sterile Ultrasound Gel is a medical device manufactured by Safersonic Us, Inc.. It received FDA 510(k) clearance on 2019-10-04 under approval 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. It is manufactured by Safersonic Us, Inc.. The 510(k) number is K190591.

When was Safergel Sterile Ultrasound Gel approved by the FDA?

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

What company makes Safergel Sterile Ultrasound Gel?

Safergel Sterile Ultrasound Gel is manufactured by Safersonic Us, Inc..

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

The FDA product code for Safergel Sterile Ultrasound Gel is MUI.

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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.