| Device Type ID | 3726 |
| Device Name | Applier, Aneurysm Clip |
| Regulation Description | Aneurysm Clip Applier. |
| 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) |
| CFR Regulation Number | 882.4175 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HCI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3726 |
| Device | Applier, Aneurysm Clip |
| Product Code | HCI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Aneurysm Clip Applier. |
| CFR Regulation Number | 882.4175 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 3 |
Difficult To Open Or Close | 1 |
| Total Device Problems | 4 |