| Device Type ID | 5668 |
| Device Name | Applier, Hemostatic Clip |
| 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 | HBT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5668 |
| Device | Applier, Hemostatic Clip |
| Product Code | HBT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 94 |
Activation, Positioning Or Separation Problem | 30 |
Difficult To Open Or Close | 14 |
Break | 4 |
Separation Failure | 4 |
Mechanical Jam | 4 |
Misfire | 3 |
Difficult To Remove | 2 |
Positioning Failure | 2 |
Failure To Form Staple | 2 |
Detachment Of Device Component | 1 |
Failure To Align | 1 |
Detachment Of Device Or Device Component | 1 |
Failure To Adhere Or Bond | 1 |
Difficult Or Delayed Positioning | 1 |
Unintended Ejection | 1 |
| Total Device Problems | 165 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Atricure Inc | II | Mar-14-2014 |
| 2 | LeMaitre Vascular, Inc. | II | Sep-14-2018 |