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FDA 510(k)

LUBRICANO-ULTRASOUND

K-Number: K083358 · 2009-01-09

ApplicantFarco Pharma GmbH
Decision Date2009-01-09
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUBRICANO-ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Farco Pharma GmbH. It received FDA 510(k) clearance on 2009-01-09 under 510(k) number K083358. 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 LUBRICANO-ULTRASOUND?

LUBRICANO-ULTRASOUND is a medical device that received FDA 510(k) clearance on 2009-01-09. The listed applicant is Farco Pharma GmbH. The 510(k) number is K083358.

When did LUBRICANO-ULTRASOUND receive FDA 510(k) clearance?

LUBRICANO-ULTRASOUND received FDA 510(k) clearance on 2009-01-09, under 510(k) number K083358.

Who is the listed applicant for LUBRICANO-ULTRASOUND?

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

What is the FDA product code for LUBRICANO-ULTRASOUND?

The FDA product code for LUBRICANO-ULTRASOUND 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 Farco Pharma GmbH 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.

K081990LUBRICANO STERILE GEL

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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