The Oncontrol Bone Access and Bone Biopsy System by Vidacare
FDA 510(k) K113872 · Vidacare Corporation
510(k) numberK113872
Submission
- Device name
- The Oncontrol Bone Access and Bone Biopsy System by Vidacare
- Applicant
- Vidacare Corporation
Irvine, CA, US - Received
- December 30, 2011
- Decision date
- March 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K260517 | Automatic Core Biopsy InstrumentKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 08/28/2026SE |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | Hologic, Inc. | 08/12/2026SE |
| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/12/2026SE |
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | Devicor Medical Products, Inc. | 03/04/2026SE |
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | Argon Medical Devices, Inc. | 02/23/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | Bard Peripheral Vascular, Inc. | 12/12/2025SE |
| K252183 | Resitu Slider 09 (RESL09)KNW · Traditional | Resitu Medical AB | 09/24/2025SE |
| K243407 | Forcyte Autograft Harvest KitKNW · Traditional | Forcyte Medical, LLC | 07/29/2025SE |
More from Forcyte Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K142377 | The OnControl Bone Marrow Biopsy System by VidacareKNW · Traditional | 12/17/2014SE |
| K141117 | Ez-Io Intraosseous Infusion SystemFMI · Traditional | 07/08/2014SE |
| K132583 | Ez-Io Intraosseous Infusion SystemFMI · Traditional | 02/11/2014SE |
| K120661 | The T.A.L.O.N. Intraossous Infusion System by VidacreFMI · Traditional | 06/03/2012SE |
| K101026 | Powered Pd-Io Infusion System, Ez-Io Humeral Head, Powered Ph-IoFMI · Traditional | 07/27/2010SE |
| K091140 | Ez-Mio Distal Tibia, Ez-Io Distal Tibia, Vidaport Intraosseous Infusion System, Ez-IoFMI · Traditional | 10/14/2009SE |
| K081713 | Vertebral Access System by VidacareMOQ · Traditional | 11/21/2008SE |
| K072045 | Oncontrol Bone Marrow Biopsy SystemKNW · Traditional | 10/22/2007SE |
| K070759 | Powered Ez-Io Pediatric Bone Marrow Aspiration SystemFCF · Traditional | 05/21/2007SE |
| K063567 | Ez-Mio SternalFMI · Traditional | 01/26/2007SE |
Questions and answers
When was The Oncontrol Bone Access and Bone Biopsy System by Vidacare cleared by the FDA?
The Oncontrol Bone Access and Bone Biopsy System by Vidacare (K113872) received a 510(k) decision of Substantially Equivalent on March 8, 2012, 69 days after the submission was received.
What is the product code of K113872?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.