Powered Ez-Io Bone Marrow Aspiration System
FDA 510(k) K062833 · Vidacare Corporation
510(k) numberK062833
Submission
- Device name
- Powered Ez-Io Bone Marrow Aspiration System
- Applicant
- Vidacare Corporation
Irvine, CA, US - Received
- September 21, 2006
- Decision date
- November 30, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCF – Instrument, Biopsy, Mechanical, Gastrointestinal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070759 | Powered Ez-Io Pediatric Bone Marrow Aspiration SystemFCF · Traditional | Vidacare Corporation | 05/21/2007SE |
| K984168 | Barrett's Esophageal Cytology DeviceFCF · Traditional | United States Endoscopy Group, Inc. | 12/07/1999SE |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | Intl. Medical, Inc. | 01/10/1992SE |
| K911155 | Oval Cup Biopsy ForcepFCF · Traditional | Endovations | 08/07/1991SE |
| K843477 | Pharma-Plast Rectal TipFCF · Traditional | Zimmar Consulting , Ltd. | 12/05/1984SE |
More from Zimmar Consulting , Ltd.
| 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 |
| K072045 | Oncontrol Bone Marrow Biopsy SystemKNW · Traditional | 10/22/2007SE |
| K070759 | Powered Ez-Io Pediatric Bone Marrow Aspiration SystemFCF · Traditional | 05/21/2007SE |
Questions and answers
When was Powered Ez-Io Bone Marrow Aspiration System cleared by the FDA?
Powered Ez-Io Bone Marrow Aspiration System (K062833) received a 510(k) decision of Substantially Equivalent on November 30, 2006, 70 days after the submission was received.
What is the product code of K062833?
The FDA product code is FCF – Instrument, Biopsy, Mechanical, Gastrointestinal, a Class II (moderate risk) device regulated under 21 CFR 876.1075.