FDA product code PIN: Kidney Perfusion Kit
PIN is the FDA product code for kidney perfusion kit. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel. Devices under PIN 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Classification
| Field | Value |
|---|---|
| Device name | Kidney Perfusion Kit |
| Device class | Class II |
| Regulation | 21 CFR 876.5880 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PIN devices
openFDA lists no recalls for product code PIN.
Frequently asked questions
What is FDA product code PIN?
PIN is the FDA product code for kidney perfusion kit. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel.
What device class is PIN?
Class II, regulation 21 CFR 876.5880. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PIN
- Run a recall and safety report across every PIN manufacturer
- Watch product code PIN 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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