Definition: The "forceps, Biopsy, Electric, Reprocessed" Are Intended To Be Used Endoscopically And Use Electric Current To (1) Obtain Tissue Samples For Histopathological Examination, (2) Allow For Coagulation So As To Prevent Bleeding, And (3) Destroy The Resi
| Device Type ID | 2024 |
| Device Name | Forceps, Biopsy, Electric, Reprocessed |
| 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 | NLU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2024 |
| Device | Forceps, Biopsy, Electric, Reprocessed |
| Product Code | NLU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
| CFR Regulation Number | 876.4300 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |