Instrument, Shunt System Implantation

Device Code: 3679

Product Code(s): GYK

Device Classification Information

• Device Type ID: 3679
• Device Name: Instrument, Shunt System Implantation
• Regulation Description: Shunt System Implantation Instrument.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurointerventional Devices Branch (NIDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 882.4545 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: GYK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 17-4 ASTM F647-94 (Reapproved 2014)
  Standard Practice For Evaluating And Specifying Implantable Shunt Assemblies For Neurosurgical Application
• 17-12 ISO 7197 Third Edition 2006-06-01
  Neurosurgical Implants - Sterile, Single-use Hydrocephalus Shunts And Components [Including: Technical Corrigendum 1 (2007)]

Total Product Life Cycle

• Device Type ID: 3679
• Device: Instrument, Shunt System Implantation
• Product Code: GYK
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Shunt System Implantation Instrument.
• CFR Regulation Number: 882.4545 [🔎]

Device Problems
Other (for Use When An Appropriate Device Code Cannot Be Identified)	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:34:17