| Device Type ID | 5597 |
| Device Name | Suture, Nonabsorbable |
| Regulation Description | Stainless Steel 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 | 878.4495 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5597 |
| Device | Suture, Nonabsorbable |
| Product Code | GAO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stainless Steel Suture. |
| CFR Regulation Number | 878.4495 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 10 |
Break | 8 |
Unsealed Device Packaging | 2 |
Split | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Suture | 1 |
Unraveled Material | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 26 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |