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The Oncontrol Bone Access and Bone Biopsy System by Vidacare

by Vidacare Corporation

510(k) K113872

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK113872 Date8 Mar 2012ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1374-2021 FDA Class II initiated 8 Mar 2021

    Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure

    • Terminated Z-0677-2017 FDA Class II initiated 8 Nov 2016

    Sterility: Due to a potential incomplete seal on the outer sterile package.

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  • Withdrawn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

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