The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Deflectable Brush Biopsy Set.
| Device ID | K191485 |
| 510k Number | K191485 |
| Device Name: | Deflectable Brush Biopsy Set |
| Classification | Endoscopic Cytology Brush |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Irasema Rivera |
| Correspondent | Irasema Rivera 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 | 2019-06-04 |
| Decision Date | 2019-06-26 |