PIY
- Product code
- PIY
- Device name
- Stainless Steel Instrument, Shunt System Implantation
- Device class
- Class 1
- 21 CFR
- 21 CFR 882.4545
- Medical specialty
- Neurology
- Marketing pathway
- 510(K) Exempt
FDA classification 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.
Official FDA classification page: PIY
Classification and pathway per current FDA publications. Data from openFDA (CC0).