| Device Type ID | 5630 |
| Device Name | Clamp, Surgical, General & Plastic Surgery |
| 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) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GDJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5630 |
| Device | Clamp, Surgical, General & Plastic Surgery |
| Product Code | GDJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STANDARD BARIATRICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 15 |
Detachment Of Device Or Device Component | 4 |
Failure To Form Staple | 4 |
Entrapment Of Device | 3 |
Fracture | 3 |
Misfire | 2 |
Detachment Of Device Component | 2 |
Air Leak | 1 |
Positioning Problem | 1 |
Failure To Align | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Jaw | 1 |
Unraveled Material | 1 |
Tip | 1 |
Device Operates Differently Than Expected | 1 |
Failure To Adhere Or Bond | 1 |
Failure To Fire | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 44 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Integra LifeSciences Corp. | II | Aug-01-2018 |