| Device Type ID | 5584 |
| Device Name | Needle, Suturing, Disposable |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GAB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5584 |
| Device | Needle, Suturing, Disposable |
| Product Code | GAB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Material Fragmentation | 22 |
Break | 13 |
Detachment Of Device Or Device Component | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Material Integrity Problem | 1 |
Material Puncture / Hole | 1 |
Device Issue | 1 |
Detachment Of Device Component | 1 |
| Total Device Problems | 43 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medline Industries Inc | II | May-25-2018 |