Stainless Steel Instrument, Shunt System Implantation

PIY · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.4545

Classification

FDA Product Code: PIY
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 882.4545
Review panel: NE
Medical specialty: Neurology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown