The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Fuse Colonoscopy System.
| Device ID | K141598 |
| 510k Number | K141598 |
| Device Name: | FUSE COLONOSCOPY SYSTEM |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | ENDOCHOICE, INC. 3 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) Caesarea, IL 3088900 |
| Contact | Tamar Fuerst |
| Correspondent | Tamar Fuerst ENDOCHOICE, INC. 3 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) Caesarea, IL 3088900 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-09-30 |
| Summary: | summary |