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Powered EZ-IO Pediatric Bone Marrow Aspiration System

by Vidacare Corporation

510(k) K070759

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 NumberK070759 Date21 May 2007ClearedStatusActive

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  • Withdrawn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
FCF
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Powered EZ-IO Pediatric Bone Marrow Aspiration System is an instrument, biopsy, mechanical, gastrointestinal device used for bone marrow aspiration. It is substantially equivalent to predicate devices and cleared under FDA 510(k) K070759.

The system consists of a reusable battery-powered driver and a disposable, single-use intraosseous aspiration needle set assembly. It is supplied with a 25mm intraosseous device and is intended for use in pediatric patients for bone marrow aspiration of the iliac crest.

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Questions

AI-generated answers, 6 Oct 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 Powered EZ-IO Pediatric Bone Marrow Aspiration System used for?

    It is used for bone marrow aspiration in pediatric patients, specifically targeting the iliac crest, as a mechanical biopsy instrument for gastrointestinal procedures.

  • How is the Powered EZ-IO Pediatric Bone Marrow Aspiration System supplied and is it reusable?

    The system includes a reusable battery-powered driver and a disposable, single-use intraosseous aspiration needle set assembly, meaning the driver can be reused while the needle set is discarded after each procedure.

  • What size intraosseous device is included with the Powered EZ-IO Pediatric Bone Marrow Aspiration System?

    The system is supplied with a 25mm intraosseous device, which is the needle length designed for pediatric use in the iliac crest during bone marrow aspiration.