| Device Type ID | 2632 |
| Device Name | Applicator, Absorbent Tipped, 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 | KXG |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2632 |
| Device | Applicator, Absorbent Tipped, Sterile |
| Product Code | KXG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Absorbent Tipped Applicator. |
| CFR Regulation Number | 880.6025 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 9 |
Insufficient Information | 2 |
Break | 1 |
Material Fragmentation | 1 |
Product Quality Problem | 1 |
Unraveled Material | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 17 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Fisher Scientific Co | II | Apr-28-2014 |
| 2 | Puritan Medical Products Co., LLC | II | Mar-13-2015 |