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FDA 510(k)

SHEATHES STERILE ULTRASOUND GEL

K-Number: K130041 · 2013-02-06

ApplicantSheathing Technologies, Inc.
Decision Date2013-02-06
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHEATHES STERILE ULTRASOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Sheathing Technologies, Inc.. It received FDA 510(k) clearance on 2013-02-06 under 510(k) number K130041. 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 SHEATHES STERILE ULTRASOUND GEL?

SHEATHES STERILE ULTRASOUND GEL is a medical device that received FDA 510(k) clearance on 2013-02-06. The listed applicant is Sheathing Technologies, Inc.. The 510(k) number is K130041.

When did SHEATHES STERILE ULTRASOUND GEL receive FDA 510(k) clearance?

SHEATHES STERILE ULTRASOUND GEL received FDA 510(k) clearance on 2013-02-06, under 510(k) number K130041.

Who is the listed applicant for SHEATHES STERILE ULTRASOUND GEL?

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

What is the FDA product code for SHEATHES STERILE ULTRASOUND GEL?

The FDA product code for SHEATHES STERILE ULTRASOUND GEL is MUI.

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Other records listing Sheathing Technologies, Inc. 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.

K153212Sheathes Ultrasound Probe CoversK112827SHEATHES ULTRASOND GELK100966COLONOSCOPE/SIGMOIDOSCOPE SHEATHESK091828SHEATHESISO ULTRASOUND TRANSDUCER COVERK043425SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)K990175SHEATHES (NON-LATEX), STERILE

View all 7 devices →

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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