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Thixo-Gel Ultrasound Spray

by Cloverline International Pharma Services GmbH

510(k) K121311

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121311 Date30 Aug 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUI
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Thixo-Gel Ultrasound Spray is a Media, Coupling, Ultrasound device designed to improve acoustic transmission between ultrasound transducers and the skin during diagnostic and therapeutic procedures. It is formulated as a gel-based medium to reduce interference from air or skin irregularities, ensuring clearer imaging or treatment delivery.

This device is supplied as a single-use, non-sterile gel intended for external application on intact skin. It is classified under FDA regulation 892.1570 and has received FDA 510(k) clearance as substantially equivalent to predicate devices. The product is distributed in standard gel spray containers and is regulated for use in radiology settings, adhering to established safety and performance standards.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Thixo-Gel Ultrasound Spray used for in clinical settings?

    The Thixo-Gel Ultrasound Spray is designed to improve acoustic transmission between ultrasound transducers and the skin during diagnostic and therapeutic procedures in radiology. It acts as a gel-based medium to minimize interference from air or skin irregularities, ensuring clearer ultrasound imaging or treatment delivery.

  • Is the Thixo-Gel Ultrasound Spray sterile, and how is it intended to be used?

    The Thixo-Gel Ultrasound Spray is supplied as a non-sterile product and is intended for single-use only. It is formulated for external application on intact skin, meaning it should only be used on unbroken skin surfaces during ultrasound procedures.

  • How is the Thixo-Gel Ultrasound Spray supplied, and what form does it take?

    The device is supplied in standard gel spray containers, allowing for easy application as an aerosolized gel. This formulation ensures convenient distribution over the skin surface during ultrasound examinations or treatments.

  • What regulatory pathway did the Thixo-Gel Ultrasound Spray follow for FDA clearance?

    The Thixo-Gel Ultrasound Spray received FDA 510(k) clearance under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to predicate devices. It is classified under FDA regulation 892.1570 and falls under the Radiology advisory committee (RA).

  • Are there multiple versions or sizes of the Thixo-Gel Ultrasound Spray, and how are they identified?

    The device is available in multiple registration numbers (e.g., 9616874, 9710018, etc.) and FEI numbers (e.g., 3008502431, 3012316249, etc.), which likely correspond to different lot or batch identifiers rather than distinct sizes or models. The product is consistently supplied as a gel spray, with no explicit size variations mentioned in the data.