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FDA 510(k)

SHEATHES ULTRASOND GEL

K-Number: K112827 · 2012-06-22

ApplicantSheathing Technologies, Inc.
Decision Date2012-06-22
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHEATHES ULTRASOND 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 2012-06-22 under 510(k) number K112827. 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 ULTRASOND GEL?

SHEATHES ULTRASOND GEL is a medical device that received FDA 510(k) clearance on 2012-06-22. The listed applicant is Sheathing Technologies, Inc.. The 510(k) number is K112827.

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

SHEATHES ULTRASOND GEL received FDA 510(k) clearance on 2012-06-22, under 510(k) number K112827.

Who is the listed applicant for SHEATHES ULTRASOND 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 ULTRASOND GEL?

The FDA product code for SHEATHES ULTRASOND 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 CoversK130041SHEATHES STERILE ULTRASOUND 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

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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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