The following data is part of a premarket notification filed by Endochoice Inc. with the FDA for Fuse Endoscopic System With Fusebox Processor.
| Device ID | K160275 |
| 510k Number | K160275 |
| Device Name: | Fuse Endoscopic System With FuseBox Processor |
| Classification | Endoscope, Accessories, Image Post-processing For Color Enhancement |
| 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 | PEA |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-08-01 |
| Summary: | summary |