| Device Type ID | 5503 |
| Device Name | Apparatus, Suturing, Stomach And Intestinal |
| 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) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FHM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5503 |
| Device | Apparatus, Suturing, Stomach And Intestinal |
| Product Code | FHM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Failure To Form Staple | 6 |
Entrapment Of Device | 5 |
Mechanics Altered | 1 |
Mechanical Problem | 1 |
Failure To Align | 1 |
Mechanical Jam | 1 |
Positioning Failure | 1 |
Leak / Splash | 1 |
Failure To Fire | 1 |
Misfire | 1 |
Component Missing | 1 |
Difficult To Open Or Close | 1 |
| Total Device Problems | 21 |