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.
| Device Type ID | 3783 |
| Device Name | Stainless Steel Instrument, Shunt System Implantation |
| Physical State | Instrument |
| Technical Method | The Device Is Used As An Instrument To Place Cerebrospinal Fluid Shunts. |
| Target Area | Cranium, Skull |
| 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 | PIY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3783 |
| Device | Stainless Steel Instrument, Shunt System Implantation |
| Product Code | PIY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Shunt System Implantation Instrument. |
| CFR Regulation Number | 882.4545 [🔎] |