The following data is part of a premarket notification filed by Boston Scientific with the FDA for Expect Slimline (sl) Endoscopic Ultrasound Aspiration Needle.
| Device ID | K173184 |
| 510k Number | K173184 |
| Device Name: | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | Boston Scientific 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Jennifer Edouard |
| Correspondent | Jennifer Edouard Boston Scientific 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-10-27 |
| Summary: | summary |