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U.S. Department of Health and Human Services

Product Classification

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Device stainless steel instrument, shunt system implantation
Regulation Description Shunt system implantation instrument.
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.
Physical State Instrument
Technical Method The device is used as an instrument to place cerebrospinal fluid shunts.
Target Area Cranium, Skull
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePIY
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type 510(K) Exempt
Regulation Number 882.4545
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible