The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Brush Biopsy Set ; Deflectable Brush Biopsy Set.
| Device ID | K182231 |
| 510k Number | K182231 |
| Device Name: | Brush Biopsy Set ; Deflectable Brush Biopsy Set |
| Classification | Endoscopic Cytology Brush |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Thomas Palmer |
| Correspondent | Chelsea Woods Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-17 |
| Decision Date | 2019-05-01 |