| Device Type ID | 1749 |
| Device Name | Tray, Biopsy, Without Biopsy Instruments |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument 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) Exempt |
| CFR Regulation Number | 876.4730 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FCH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1749 |
| Device | Tray, Biopsy, Without Biopsy Instruments |
| Product Code | FCH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument And Accessories. |
| CFR Regulation Number | 876.4730 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Custom Medical Specialties, Inc. | II | Feb-22-2017 |
| 2 | Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables | II | Dec-22-2016 |