| Device Type ID | 3950 |
| Device Name | Electrocautery, Gynecologic (and Accessories) |
| Regulation Description | Gynecologic Electrocautery 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 | 884.4120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HGI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3950 |
| Device | Electrocautery, Gynecologic (and Accessories) |
| Product Code | HGI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gynecologic Electrocautery And Accessories. |
| CFR Regulation Number | 884.4120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DOMAIN SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIGER MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 4 |
Material Integrity Problem | 3 |
Melted | 3 |
Sparking | 2 |
Material Deformation | 2 |
Material Fragmentation | 2 |
Electrical Wires, Defective | 1 |
Wire(s), Breakage Of | 1 |
Detachment Of Device Component | 1 |
Peeled / Delaminated | 1 |
Arcing | 1 |
Overheating Of Device | 1 |
Fire | 1 |
Fracture | 1 |
Product Quality Problem | 1 |
Electronic Property Issue | 1 |
Circuit Failure | 1 |
Intermittent Continuity | 1 |
Electrical /Electronic Property Problem | 1 |
Connection Problem | 1 |
| Total Device Problems | 30 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | May-15-2018 |
| 2 | CooperSurgical, Inc. | II | Dec-02-2014 |