Humeral Head, Manual Driver
FDA 510(k) K062422 · Vidacare Corporation
510(k) numberK062422
Submission
- Device name
- Humeral Head, Manual Driver
- Applicant
- Vidacare Corporation
Irvine, CA, US - Received
- August 18, 2006
- Decision date
- November 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
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| 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 Humeral Head, Manual Driver cleared by the FDA?
Humeral Head, Manual Driver (K062422) received a 510(k) decision of Substantially Equivalent on November 7, 2006, 81 days after the submission was received.
What is the product code of K062422?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.