Definition: Intended To Cut A Hole In Finger And Toe Nails To Release Fluid Accumulated In The Underlying Nail Bed. Indicated To Relieve Pressure From Subungual Hematomas (including Black Toe).
| Device Type ID | 5788 |
| Device Name | Drill, Battery Powered, Subungual Hematoma |
| Physical State | The Device Is Comprised Of A Hand-held Cutter, Sensing Electrodes And A Battery Pack. |
| Technical Method | The Device Uses A 6V Cutter Motor To Rotate The Cutter And A 6V Vertical Drive Motor To Move The Cutter Towards And Away From The Nail. The Motors Are Powered By A 9V Battery. |
| Target Area | Finger Nails And Toe Nails. |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| 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 | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NWF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5788 |
| Device | Drill, Battery Powered, Subungual Hematoma |
| Product Code | NWF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Failure To Shut Off | 1 |
Device Remains Activated | 1 |
| Total Device Problems | 2 |