Skip to content

Ultrasound Coupling Gel

by Geno Laboratories

510(k) K904418

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904418 Date11 Feb 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JOT
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

Ultrasound Coupling Gel is a medical device designed to facilitate the transmission of ultrasound waves between the transducer and the skin during diagnostic imaging procedures. It ensures optimal acoustic contact, improving image clarity and accuracy in medical examinations.

The gel is supplied sterile and intended for single-use applications. It is compatible with MRI systems and should be stored in a cool, dry place away from direct sunlight. The device is regulated under FDA 510(k) clearance, with a decision of Substantially Equivalent.

Questions

AI-generated answers, 23 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 Ultrasound Coupling Gel used for?

    Ultrasound Coupling Gel is used to facilitate the transmission of ultrasound waves between the transducer and the skin during diagnostic imaging procedures, ensuring optimal acoustic contact and improving image clarity.

  • Is the gel sterile and intended for single use?

    Yes, the gel is supplied sterile and is intended for single-use applications to maintain hygiene and prevent cross-contamination.

  • How should the gel be stored?

    The gel should be stored in a cool, dry place away from direct sunlight to preserve its quality and effectiveness.

  • Is the gel compatible with MRI systems?

    Yes, the gel is compatible with MRI systems, making it suitable for use in various imaging environments.