Device Type ID | 3715 |
Device Name | Instrument, Clip Forming/cutting |
Regulation Description | Clip Forming/cutting Instrument. |
Regulation Medical Specialty | Neurology |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 882.4190 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HBS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3715 |
Device | Instrument, Clip Forming/cutting |
Product Code | HBS |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Clip Forming/cutting Instrument. |
CFR Regulation Number | 882.4190 [🔎] |
Device Problems | |
---|---|
Overheating Of Device | 1 |
Total Device Problems | 1 |