The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Bonastent Biliary.
| Device ID | K140760 |
| 510k Number | K140760 |
| Device Name: | BONASTENT BILIARY |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ENDOCHOICE, INC. 1208-12 ROCKFORD RD. Toronto, On, CA M2r 3a2 |
| Contact | Bosmat Friedman |
| Correspondent | Bosmat Friedman ENDOCHOICE, INC. 1208-12 ROCKFORD RD. Toronto, On, CA M2r 3a2 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-26 |
| Decision Date | 2014-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806369461528 | K140760 | 000 |
| 08806369461160 | K140760 | 000 |
| 08806369461184 | K140760 | 000 |
| 08806369461207 | K140760 | 000 |
| 08806369461221 | K140760 | 000 |
| 08806369461245 | K140760 | 000 |
| 08806369461429 | K140760 | 000 |
| 08806369461443 | K140760 | 000 |
| 08806369461467 | K140760 | 000 |
| 08806369461481 | K140760 | 000 |
| 08806369461504 | K140760 | 000 |
| 08806369461146 | K140760 | 000 |