Definition: Same As Procode FCL Except This Product Is For The Reprocessed Device.
| Device Type ID | 2038 |
| Device Name | Forceps, Biopsy, Non-electric, Reprocessed |
| Regulation Description | Gastroenterology-urology Biopsy Instrument. |
| 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 | 876.1075 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NON |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2038 |
| Device | Forceps, Biopsy, Non-electric, Reprocessed |
| Product Code | NON |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Gastroenterology-urology Biopsy Instrument. |
| CFR Regulation Number | 876.1075 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 18 |
Break | 13 |
Material Integrity Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 33 |