| Device Type ID | 5593 |
| Device Name | Suture, Absorbable |
| Regulation Description | Absorbable Surgical Gut Suture. |
| 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) |
| CFR Regulation Number | 878.4830 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5593 |
| Device | Suture, Absorbable |
| Product Code | GAK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Absorbable Surgical Gut Suture. |
| CFR Regulation Number | 878.4830 [🔎] |
| Device Problems | |
|---|---|
Product Quality Problem | 19 |
Break | 6 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Appropriate Term/Code Not Available | 3 |
Detachment Of Device Component | 3 |
Detachment Of Device Or Device Component | 2 |
Material Erosion | 1 |
Degraded | 1 |
Unraveled Material | 1 |
| Total Device Problems | 40 |