| Device Type ID | 5680 |
| Device Name | Rasp |
| Regulation Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HTR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5680 |
| Device | Rasp |
| Product Code | HTR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Fracture | 26 |
Break | 21 |
Fitting Problem | 6 |
Material Deformation | 4 |
Device Markings / Labelling Problem | 4 |
Difficult To Remove | 4 |
Use Of Device Problem | 3 |
Appropriate Term/Code Not Available | 2 |
Device Operates Differently Than Expected | 2 |
Crack | 2 |
Mechanical Jam | 2 |
Complete Blockage | 1 |
Material Fragmentation | 1 |
Device-Device Incompatibility | 1 |
Detachment Of Device Component | 1 |
Sticking | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Switch, Push Button | 1 |
Corroded | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Device Dislodged Or Dislocated | 1 |
Label | 1 |
Misassembled | 1 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 91 |