Product Classification

• Device: shunt, central nervous system and components
• Regulation Description: Central nervous system fluid shunt and components.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: JXG
• Submission Type: 510(k)
• Regulation Number: 882.5550
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 7197:2006 Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components
• ASTM F647-94 (Reapproved 2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
• ISO 7197:2006 Technical Corrigendum1:2007 Neurological implants - Sterile, single-use hydrocephalus shunts and components

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.