510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PIYClass I

Stainless Steel Instrument, Shunt System Implantation

21 CFR 882.4545 / Neurology
FDA source (opens on fda.gov)

PIY is the FDA product code for Stainless Steel Instrument, Shunt System Implantation, a class I device type, regulated under 21 CFR 882.4545. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PIY
Device name
Stainless Steel Instrument, Shunt System Implantation
FDA 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.
Regulation
21 CFR 882.4545
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code