| Device Type ID | 1751 |
| Device Name | Instrument, Biopsy, Suction |
| 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 2 Medical Device |
| Product Code | FCK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1751 |
| Device | Instrument, Biopsy, Suction |
| Product Code | FCK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastroenterology-urology Biopsy Instrument. |
| CFR Regulation Number | 876.1075 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |