| Device Type ID | 2601 |
| Device Name | Fiber, Medical, Absorbent |
| Regulation Description | Medical Absorbent Fiber. |
| 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 | 880.5300 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FRL |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2601 |
| Device | Fiber, Medical, Absorbent |
| Product Code | FRL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Medical Absorbent Fiber. |
| CFR Regulation Number | 880.5300 [🔎] |
| Device Problems | |
|---|---|
Material Frayed | 5 |
Material Separation | 4 |
Incomplete Or Missing Packaging | 3 |
Flaked | 2 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Sticking | 1 |
Failure To Obtain Sample | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Physical Property Issue | 1 |
Material Integrity Problem | 1 |
Device Reprocessing Problem | 1 |
Material Disintegration | 1 |
| Total Device Problems | 23 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Surgical Company | II | May-26-2016 |
| 2 | Medical Action Industries Inc | II | May-31-2018 |