| Device Type ID | 2631 |
| Device Name | Applicator, Absorbent Tipped, Non-sterile |
| Regulation Description | Absorbent Tipped Applicator. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6025 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KXF |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2631 |
| Device | Applicator, Absorbent Tipped, Non-sterile |
| Product Code | KXF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Absorbent Tipped Applicator. |
| CFR Regulation Number | 880.6025 [🔎] |
| Device Problems | |
|---|---|
Break | 12 |
Material Separation | 6 |
Loss Of Or Failure To Bond | 5 |
Use Of Device Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Fire | 1 |
Detachment Of Device Or Device Component | 1 |
Thermal Decomposition Of Device | 1 |
| Total Device Problems | 30 |