Oncontrol Bone Marrow Biopsy System
FDA 510(k) K072045 · Vidacare Corporation
510(k) numberK072045
Submission
- Device name
- Oncontrol Bone Marrow Biopsy System
- Applicant
- Vidacare Corporation
Irvine, CA, US - Received
- July 25, 2007
- Decision date
- October 22, 2007
- 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
Other 510(k)s with product code KNW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K113872 | The Oncontrol Bone Access and Bone Biopsy System by VidacareKNW · Traditional | 03/08/2012SE |
| 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 |
| 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 Oncontrol Bone Marrow Biopsy System cleared by the FDA?
Oncontrol Bone Marrow Biopsy System (K072045) received a 510(k) decision of Substantially Equivalent on October 22, 2007, 89 days after the submission was received.
What is the product code of K072045?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.