FDA product code SIW: Robotic Peripheral Venous Blood Collection System
SIW is the FDA product code for robotic peripheral venous blood collection system. It is a Class II device, regulated under 21 CFR 880.6975 and reviewed by the General Hospital panel. Devices under SIW reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A robotic peripheral venous blood collection system is an electromechanical device used to obtain blood samples from peripheral veins for diagnostic purposes. The device uses robotic systems to assist with the blood collection procedure, including vessel identification, targeting, and/or needle insertion, and may perform its functions in an automated or autonomous manner.
Classification
| Field | Value |
|---|---|
| Device name | Robotic Peripheral Venous Blood Collection System |
| Device class | Class II |
| Regulation | 21 CFR 880.6975 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for SIW devices
openFDA lists no recalls for product code SIW.
Frequently asked questions
What is FDA product code SIW?
SIW is the FDA product code for robotic peripheral venous blood collection system. It is a Class II device, regulated under 21 CFR 880.6975 and reviewed by the General Hospital panel.
What device class is SIW?
Class II, regulation 21 CFR 880.6975. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIW
- Run a recall and safety report across every SIW manufacturer
- Watch product code SIW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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