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Everytime Transfucer Cover

by Amedic AB

510(k) K955893

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 NumberK955893 Date30 Dec 1997ClearedStatusActive

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  • Withdrawn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
ITX
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 Everytime Transducer Cover is a protective barrier classified as a transducer cover (product code ITX), designed to shield diagnostic ultrasound transducers during use. It serves as a physical barrier to prevent cross-contamination between patients and the transducer, ensuring hygiene in radiology imaging procedures.

This single-use device is supplied sterile and intended for one-time clinical application. It is regulated under FDA 510(k) clearance (K955893) and falls under the Radiology advisory committee’s review. No MRI safety classification or reusable specifications are stated in the regulatory filing.

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 Everytime Transducer Cover specifically designed to protect during ultrasound procedures?

    The Everytime Transducer Cover is a single-use sterile barrier designed to shield diagnostic ultrasound transducers from direct contact with patients. Its primary purpose is to create a physical barrier that prevents cross-contamination between the transducer and the patient, ensuring hygiene in radiology imaging.

  • Is the Everytime Transducer Cover reusable, or is it meant for one-time clinical use?

    The Everytime Transducer Cover is explicitly labeled as a single-use device, meaning it is intended for one-time clinical application only. This design ensures patient safety and hygiene by preventing reuse, which could introduce contamination risks.

  • How is the Everytime Transducer Cover supplied, and does it require any special handling before use?

    The Everytime Transducer Cover is supplied sterile and ready for immediate clinical use. Since it is single-use, no additional sterilization or preparation is required—simply peel it open and apply it to the transducer before use.

  • What regulatory pathway was followed for the FDA clearance of the Everytime Transducer Cover?

    The Everytime Transducer Cover received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). It was reviewed by the Radiology (RA) Advisory Committee and classified under product code ITX (transducer cover). The clearance number is K955893.