The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Endoscopic Cap, Check-flo Adapter, Side-arm Adapter, Tuohy-borst Adapter.
| Device ID | K173105 |
| 510k Number | K173105 |
| Device Name: | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter |
| Classification | Endoscope Channel Accessory |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Samuel Engelman |
| Correspondent | Samuel Engelman Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-03-22 |
| Summary: | summary |