FDA product code PWZ: Mid-Stream Collection Kit
PWZ is the FDA product code for mid-stream collection kit. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel. Devices under PWZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Mid-Stream Collection Kit |
| Device class | Class I |
| Regulation | 21 CFR 880.6730 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PWZ devices
openFDA lists no recalls for product code PWZ.
Frequently asked questions
What is FDA product code PWZ?
PWZ is the FDA product code for mid-stream collection kit. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel.
What device class is PWZ?
Class I, regulation 21 CFR 880.6730. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PWZ
- Run a recall and safety report across every PWZ manufacturer
- Watch product code PWZ 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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