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OnControl Bone Marrow Biopsy System

by Vidacare Corporation

510(k) K072045

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 NumberK072045 Date22 Oct 2007ClearedStatusActive

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  • Withdrawn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
KNW
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 OnControl Bone Marrow Biopsy System is a powered device intended for bone marrow aspiration and biopsy in adult and pediatric patients age 2 and older. It utilizes a power rotary driver to facilitate the collection of bone marrow samples.

The system consists of a reusable power driver and a disposable sterile needle set provided in a sealed procedure tray. The tray includes a driver connector with a sterile sleeve, a biopsy needle set with a depth guide, an ejector rod, and an alignment guide.

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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 intended use of the OnControl Bone Marrow Biopsy System?

    The OnControl system is indicated for bone marrow aspiration and biopsy procedures in both adult and pediatric patients who are at least 2 years of age.

  • How is the OnControl Bone Marrow Biopsy System supplied?

    The system is supplied as a combination of a reusable power driver and a disposable sterile needle set. These components are provided together in a sealed procedure tray to ensure they are ready for clinical use.

  • What components are included in the procedure tray?

    The procedure tray contains the biopsy needle set, a driver connector with a sterile sleeve, an ejector rod, and an alignment guide. The inclusion of a depth guide helps clinicians manage the needle placement during the collection process.