| Device Type ID | 1730 |
| Device Name | Electrode, Electrosurgical, Active, Urological |
| Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FAS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1730 |
| Device | Electrode, Electrosurgical, Active, Urological |
| Product Code | FAS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
| CFR Regulation Number | 876.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OLYMPUS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OMNITECH SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 175 |
Electrode | 46 |
Fracture | 31 |
Material Fragmentation | 31 |
Mechanical Problem | 28 |
Tip | 21 |
Sparking | 16 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Cord | 6 |
Arcing Of Electrodes | 6 |
Thermal Decomposition Of Device | 6 |
Charred | 5 |
Material Separation | 5 |
Detachment Of Device Component | 5 |
Electrical Shorting | 4 |
Device Or Device Fragments Location Unknown | 4 |
Melted | 4 |
Wire | 4 |
Cable | 4 |
Fire | 4 |
Output Problem | 3 |
Crack | 3 |
Overheating Of Device | 3 |
Insufficient Information | 3 |
Temperature Problem | 2 |
Component Falling | 2 |
Material Deformation | 2 |
Device Operates Differently Than Expected | 2 |
Component Missing | 2 |
Failure To Cut | 1 |
Electrical /Electronic Property Problem | 1 |
Misassembled | 1 |
Insulation | 1 |
Material Disintegration | 1 |
Product Quality Problem | 1 |
Flare Or Flash | 1 |
Power Cord | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Arcing | 1 |
Device Issue | 1 |
Separation Failure | 1 |
Device Damaged By Another Device | 1 |
Mechanical Jam | 1 |
Device Handling Problem | 1 |
Hole In Material | 1 |
Loss Of Power | 1 |
Failure To Deliver Energy | 1 |
Entrapment Of Device | 1 |
Flaked | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Mechanics Altered | 1 |
Cautery | 1 |
Split | 1 |
| Total Device Problems | 458 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Nov-16-2016 |
| 2 | Gyrus Acmi, Incorporated | II | May-29-2018 |
| 3 | Olympus Corporation Of The Americas | II | Dec-14-2016 |