| Device Type ID | 3696 |
| Device Name | Rongeur, Manual |
| Regulation Description | Manual Rongeur. |
| 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 | 882.4840 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HAE |
| 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 | 3696 |
| Device | Rongeur, Manual |
| Product Code | HAE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Manual Rongeur. |
| CFR Regulation Number | 882.4840 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GERALD FEHLING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K2 MEDICAL GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RJR SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYMMETRY SURGICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITALITEC MEDIZINTECHNIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fracture | 14 |
Break | 8 |
Inadequate Service | 7 |
Appropriate Term/Code Not Available | 7 |
Maintenance Does Not Comply To Manufacturers Recommendations | 5 |
Dent In Material | 5 |
Misassembly By Users | 4 |
Failure To Cut | 4 |
Bent | 4 |
Device Operates Differently Than Expected | 3 |
Device Handling Problem | 3 |
Detachment Of Device Component | 3 |
Insufficient Information | 3 |
Missing Value Reason | 3 |
Difficult To Advance | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Device Dislodged Or Dislocated | 2 |
Screw | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Shaft | 1 |
Component Missing | 1 |
Component Falling | 1 |
Loose Or Intermittent Connection | 1 |
Mechanical Problem | 1 |
Material Fragmentation | 1 |
Material Separation | 1 |
| Total Device Problems | 91 |