| Device Type ID | 1954 |
| Device Name | Forceps, Biopsy, Electric |
| 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 | KGE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1954 |
| Device | Forceps, Biopsy, Electric |
| Product Code | KGE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
| CFR Regulation Number | 876.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO-TECH (NAN JING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OVESCO ENDOSCOPY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SLATER ENDOSCOPY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Deliver Energy | 37 |
Tear, Rip Or Hole In Device Packaging | 27 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Break | 9 |
Failure To Align | 6 |
Device Handling Problem | 6 |
Device Operates Differently Than Expected | 6 |
Tip | 2 |
No Apparent Adverse Event | 2 |
Material Fragmentation | 2 |
Off-Label Use | 1 |
Material Separation | 1 |
Separation Failure | 1 |
Detachment Of Device Component | 1 |
Arcing | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Detachment Of Device Or Device Component | 1 |
Output Problem | 1 |
Mechanical Problem | 1 |
Dull, Blunt | 1 |
Activation Problem | 1 |
Difficult To Open Or Close | 1 |
Material Frayed | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Inappropriate Shock | 1 |
Solder Joint Fracture | 1 |
| Total Device Problems | 124 |