| Device Type ID | 3693 |
| Device Name | Retractor, Self-retaining, For Neurosurgery |
| Regulation Description | Self-retaining Retractor For Neurosurgery. |
| 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) |
| CFR Regulation Number | 882.4800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GZT |
| 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 | 3693 |
| Device | Retractor, Self-retaining, For Neurosurgery |
| Product Code | GZT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Self-retaining Retractor For Neurosurgery. |
| CFR Regulation Number | 882.4800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FETZER MEDICAL GMBH & CO.KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GEISTER MEDIZINTECHN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICON, E.G. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NICO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TEDAN SURGICAL INNOVATIONS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Deformation | 1 |
Device Damaged Prior To Use | 1 |
Crack | 1 |
Device Slipped | 1 |
Defective Component | 1 |
Solder Joint Fracture | 1 |
Material Integrity Problem | 1 |
Handpiece | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Retraction Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nico Corp. | II | Aug-14-2018 |