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 | K163058 |
| 510k Number | K163058 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-01 |
| Decision Date | 2017-01-30 |
| Summary: | summary |