The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spyglass Ds And Ds Ii Direct Visualization System.
| Device ID | K181439 |
| 510k Number | K181439 |
| Device Name: | SpyGlass DS And DS II Direct Visualization System |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Carter Navarro |
| Correspondent | Jennifer Kimball Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | FBN |
| Subsequent Product Code | KQM |
| Subsequent Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2018-08-23 |
| Summary: | summary |