Definition: To Collect Cells For Cytological Evaluation.
| Device Type ID | 1777 |
| Device Name | Endoscopic Cytology Brush |
| Physical State | Brush And Shaft |
| Technical Method | Brush Goes Through Endoscope To Desired Location And Rotates To Remove And Collect Cells. |
| Target Area | Various Tissues In Gi And Gu Tract |
| Regulation Description | Endoscope 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 | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FDX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1777 |
| Device | Endoscopic Cytology Brush |
| Product Code | FDX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MICRO-TECH (NAN JING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 68 |
Wire | 56 |
Brush | 39 |
Bent | 25 |
Adverse Event Without Identified Device Or Use Problem | 18 |
Material Twisted / Bent | 16 |
Detachment Of Device Component | 15 |
Patient-Device Incompatibility | 11 |
Retraction Problem | 11 |
Mechanical Problem | 8 |
Ring | 5 |
Device Contamination With Chemical Or Other Material | 3 |
Material Deformation | 3 |
Catheter | 3 |
Use Of Device Problem | 2 |
Material Separation | 2 |
Detachment Of Device Or Device Component | 2 |
Difficult To Advance | 1 |
Device Handling Problem | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
| Total Device Problems | 291 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hobbs Medical, Inc. | II | Jun-01-2018 |