The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Endochoice Water Bottle Cap Irrigation System.
| Device ID | K161482 |
| 510k Number | K161482 |
| Device Name: | EndoChoice Water Bottle Cap Irrigation System |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | ENDOCHOICE, INC. 11810 WILLS RD. Alpharetta, GA 30009 |
| Contact | Dainel Hoefer |
| Correspondent | Daniel Hoefer ENDOCHOICE, INC. 11810 WILLS RD. Alpharetta, GA 30009 |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-31 |
| Decision Date | 2016-06-27 |
| Summary: | summary |