THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE— 510(k) K113872
Substantially EquivalentVidacare Corporation
FDA 510(k) clearance K113872 for THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE, Substantially Equivalent on 2012-03-08. Applicant: Vidacare Corporation. Device class: 2.
Clearance details
- Applicant
- Vidacare Corporation
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code KNW
view allMore clearances from Vidacare Corporation
view all- K132583 — EZ-IO INTRAOSSEOUS INFUSION SYSTEM
- K120661 — THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
- K101026 — POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
- K091140 — EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
- K081713 — VERTEBRAL ACCESS SYSTEM BY VIDACARE
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K113872
K-number listed on FDA's recall record- Z-1374-2021 — Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
- Z-0677-2017 — ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113872.
Data sourced from openFDA. This site is unofficial and independent of the FDA.