| Device Type ID | 5458 |
| Device Name | Device, Endoscopic Suturing |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 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 | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MFJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5458 |
| Device | Device, Endoscopic Suturing |
| Product Code | MFJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Break | 7 |
Detachment Of Device Component | 3 |
Torn Material | 2 |
Detachment Of Device Or Device Component | 1 |
Mechanical Jam | 1 |
Difficult Or Delayed Positioning | 1 |
| Total Device Problems | 15 |