PIY — Stainless Steel Instrument, Shunt System Implantation Class I
FDA product code PIY covers "Stainless Steel Instrument, Shunt System Implantation", a Class I medical device regulated under 21 CFR 882.4545. Submissions are reviewed by the Neurology panel.
Classification Details
- Product Code
- PIY
- Device Class
- Class I
- Regulation Number
- 882.4545
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.