| Device Type ID | 3998 |
| Device Name | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Regulation Description | Unipolar Endoscopic Coagulator-cutter And Accessories. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.4160 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KNF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3998 |
| Device | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Product Code | KNF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Unipolar Endoscopic Coagulator-cutter And Accessories. |
| CFR Regulation Number | 884.4160 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GYNESONICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GYNESONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LINA MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fire | 8 |
Break | 7 |
Thermal Decomposition Of Device | 5 |
Electrical /Electronic Property Problem | 3 |
Failure To Cut | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Sparking | 2 |
Overheating Of Device | 2 |
Temperature Problem | 2 |
Torn Material | 2 |
Material Fragmentation | 2 |
Device Handling Problem | 2 |
Material Separation | 1 |
Out-Of-Box Failure | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Arcing | 1 |
Unintended Movement | 1 |
Detachment Of Device Or Device Component | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Device Operates Differently Than Expected | 1 |
Unintended Electrical Shock | 1 |
Material Disintegration | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Misassembled | 1 |
Contamination / Decontamination Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Smoking | 1 |
Metal Shedding Debris | 1 |
| Total Device Problems | 56 |