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FDA 510(k)

UNI-PATCH ULTRASOUND COUPLING GEL

K-Number: K021132 · 2002-05-15

ApplicantThe Ludlow Company LP
Decision Date2002-05-15
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNI-PATCH ULTRASOUND COUPLING GEL is the device name listed in this FDA 510(k) record. The listed applicant is The Ludlow Company LP. It received FDA 510(k) clearance on 2002-05-15 under 510(k) number K021132. 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 UNI-PATCH ULTRASOUND COUPLING GEL?

UNI-PATCH ULTRASOUND COUPLING GEL is a medical device that received FDA 510(k) clearance on 2002-05-15. The listed applicant is The Ludlow Company LP. The 510(k) number is K021132.

When did UNI-PATCH ULTRASOUND COUPLING GEL receive FDA 510(k) clearance?

UNI-PATCH ULTRASOUND COUPLING GEL received FDA 510(k) clearance on 2002-05-15, under 510(k) number K021132.

Who is the listed applicant for UNI-PATCH ULTRASOUND COUPLING GEL?

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

What is the FDA product code for UNI-PATCH ULTRASOUND COUPLING GEL?

The FDA product code for UNI-PATCH ULTRASOUND COUPLING GEL is MUI.

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Other records listing The Ludlow Company LP 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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESK003511KENDALL-LTP TURNER SAVE-A-LINE

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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