The following data is part of a premarket notification filed by Endochoice Inc. with the FDA for Fuse Gastroscopy System.
| Device ID | K152182 |
| 510k Number | K152182 |
| Device Name: | Fuse Gastroscopy System |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | ENDOCHOICE INC. 11810 WILLS RD. Alpharetta, GA 30009 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer ENDOCHOICE INC. 11810 WILLS RD. Alpharetta, GA 30009 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-05 |
| Decision Date | 2015-12-10 |
| Summary: | summary |