| Device Type ID | 5765 |
| Device Name | System, Ablation, Microwave And Accessories |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| 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 Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NEY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5765 |
| Device | System, Ablation, Microwave And Accessories |
| Product Code | NEY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANGIODYNAMICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANGIODYNAMICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BSD MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDWAVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MIRAMAR LABS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEUWAVE MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUWAVE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Temperature Problem | 180 |
Adverse Event Without Identified Device Or Use Problem | 43 |
Bent | 31 |
Detachment Of Device Component | 28 |
Insufficient Information | 22 |
Device Displays Incorrect Message | 21 |
Fracture | 19 |
Break | 17 |
Detachment Of Device Or Device Component | 13 |
Crack | 12 |
Failure To Fire | 7 |
No Flow | 7 |
Flare Or Flash | 6 |
Device Operates Differently Than Expected | 5 |
Connection Problem | 5 |
Leak / Splash | 5 |
Alarm, Audible | 4 |
Device Remains Activated | 4 |
Device Stops Intermittently | 4 |
Peeled / Delaminated | 3 |
Electrical Shorting | 2 |
Material Fragmentation | 2 |
Flaked | 2 |
Difficult To Insert | 2 |
Device Damaged Prior To Use | 2 |
Overheating Of Device | 2 |
Antenna | 2 |
Material Twisted / Bent | 2 |
Deformation Due To Compressive Stress | 2 |
Failure To Deliver | 1 |
Tip | 1 |
Failure To Reset | 1 |
Difficult To Remove | 1 |
Energy Output Problem | 1 |
Device Inoperable | 1 |
Unstable | 1 |
Material Integrity Problem | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Output Problem | 1 |
Needle | 1 |
Dull, Blunt | 1 |
Unsealed Device Packaging | 1 |
Material Separation | 1 |
Device Issue | 1 |
Computer Operating System Problem | 1 |
Failure To Deliver Energy | 1 |
| Total Device Problems | 472 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiodynamics, Inc. | II | Feb-05-2018 |
| 2 | Covidien LLC | II | Dec-18-2018 |
| 3 | Covidien LLC | II | Feb-09-2018 |
| 4 | Covidien Medical Products (Shanghai) Manufacturing L.L.C. | II | Mar-17-2016 |