FDA product code PIY: Stainless Steel Instrument, Shunt System Implantation
PIY is the FDA product code for stainless steel instrument, shunt system implantation. It is a Class I device, regulated under 21 CFR 882.4545 and reviewed by the Neurology panel. Devices under PIY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A stainless steel shunt system implantation instrument is an instrument made entirely of stainless steel used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.
Classification
| Field | Value |
|---|---|
| Device name | Stainless Steel Instrument, Shunt System Implantation |
| Device class | Class I |
| Regulation | 21 CFR 882.4545 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for PIY devices
openFDA lists no recalls for product code PIY.
Frequently asked questions
What is FDA product code PIY?
PIY is the FDA product code for stainless steel instrument, shunt system implantation. It is a Class I device, regulated under 21 CFR 882.4545 and reviewed by the Neurology panel.
What device class is PIY?
Class I, regulation 21 CFR 882.4545. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PIY
- Run a recall and safety report across every PIY manufacturer
- Watch product code PIY 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.