FDA 510(k)

Ultrast Gel

K-Number: K211691 · 2021-12-22

Decision Date2021-12-22

Product CodeMUI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ultrast Gel is the device name listed in this FDA 510(k) record. The listed applicant is Ultrast, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K211691. 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 Ultrast Gel?

Ultrast Gel is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Ultrast, Inc.. The 510(k) number is K211691.

When did Ultrast Gel receive FDA 510(k) clearance?

Ultrast Gel received FDA 510(k) clearance on 2021-12-22, under 510(k) number K211691.

Who is the listed applicant for Ultrast Gel?

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

What is the FDA product code for Ultrast Gel?

The FDA product code for Ultrast Gel 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.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.