FDA 510(k)

ONCONTROL BONE MARROW BIOPSY SYSTEM

K-Number: K072045 · 2007-10-22

Decision Date2007-10-22

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ONCONTROL BONE MARROW BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vidacare Corporation. It received FDA 510(k) clearance on 2007-10-22 under 510(k) number K072045. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONCONTROL BONE MARROW BIOPSY SYSTEM?

ONCONTROL BONE MARROW BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-22. The listed applicant is Vidacare Corporation. The 510(k) number is K072045.

When did ONCONTROL BONE MARROW BIOPSY SYSTEM receive FDA 510(k) clearance?

ONCONTROL BONE MARROW BIOPSY SYSTEM received FDA 510(k) clearance on 2007-10-22, under 510(k) number K072045.

Who is the listed applicant for ONCONTROL BONE MARROW BIOPSY SYSTEM?

The FDA 510(k) record lists Vidacare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONCONTROL BONE MARROW BIOPSY SYSTEM?

The FDA product code for ONCONTROL BONE MARROW BIOPSY SYSTEM is KNW.

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Other records listing Vidacare Corporation as applicant

K120661THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE K113872THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE K101026POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO K091140EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO K081713VERTEBRAL ACCESS SYSTEM BY VIDACARE K070759POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.