FDA product code · Neurology

Stainless Steel Instrument, Shunt System Implantation

Name: FDA decisions, review times, recalls and adverse event reports for product code PIY
Creator: 510(k) Report

PIYClass I21 CFR 882.4545510(k) exempt0 decisions0 recalls

FDA lists PIY as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 882.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of PIY at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — PIY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PIY? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 882.4545.

GYK Instrument, Shunt System Implantation