| Device Type ID | 5669 |
| Device Name | Instrument, Ligature Passing And Knot Tying |
| 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 | HCF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5669 |
| Device | Instrument, Ligature Passing And Knot Tying |
| Product Code | HCF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 40 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Fracture | 3 |
Device Operates Differently Than Expected | 2 |
Difficult To Open Or Close | 2 |
Activation, Positioning Or Separation Problem | 1 |
Material Frayed | 1 |
Material Twisted / Bent | 1 |
Suture | 1 |
Failure To Fire | 1 |
Mechanical Problem | 1 |
Insufficient Information | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 63 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical | II | Dec-14-2016 |
| 2 | Teleflex Medical | II | Aug-15-2016 |