ONCONTROL BONE MARROW BIOPSY SYSTEM— 510(k) K072045
Substantially EquivalentVidacare Corporation
FDA 510(k) clearance K072045 for ONCONTROL BONE MARROW BIOPSY SYSTEM, Substantially Equivalent on 2007-10-22. 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
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view all- K132583 — EZ-IO INTRAOSSEOUS INFUSION SYSTEM
- K120661 — THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
- K113872 — THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
- 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
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.