| Device Type ID | 5596 |
| Device Name | Suture, Absorbable, Synthetic |
| 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 | GAN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5596 |
| Device | Suture, Absorbable, Synthetic |
| Product Code | GAN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Absorbable Surgical Gut Suture. |
| CFR Regulation Number | 878.4830 [🔎] |
| Device Problems | |
|---|---|
Break | 240 |
Appropriate Term/Code Not Available | 142 |
Material Separation | 95 |
Detachment Of Device Component | 79 |
Detachment Of Device Or Device Component | 21 |
Adverse Event Without Identified Device Or Use Problem | 17 |
Tear, Rip Or Hole In Device Packaging | 17 |
Component Incompatible | 8 |
Unsealed Device Packaging | 7 |
Incorrect Device Or Component Shipped | 4 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 4 |
Migration Or Expulsion Of Device | 3 |
Bent | 2 |
Suture | 1 |
Failure To Adhere Or Bond | 1 |
Component Misassembled | 1 |
Extrusion | 1 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 644 |