The following data is part of a premarket notification filed by Endocure Technologies, Inc. with the FDA for Endocure Model Eur078a.
| Device ID | K161147 |
| 510k Number | K161147 |
| Device Name: | EndoCure Model EUR078A |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | ENDOCURE TECHNOLOGIES, INC. 5801 AMMENDALE ROAD, SUITE A Beltsville, MD 20705 |
| Contact | Charles J. Neff |
| Correspondent | E.j. Smith SMITH ASSOCIATES 1468 HARWELL AVENUE Crofton, MD 21114 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-22 |
| Decision Date | 2016-06-07 |
| Summary: | summary |