The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Expect Slimline Endoscopic Ultrasound Aspiration Needle.
| Device ID | K133312 |
| 510k Number | K133312 |
| Device Name: | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Yingying Gao |
| Correspondent | Yingying Gao Boston Scientific Corporation 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 | 2013-10-28 |
| Decision Date | 2014-01-03 |
| Summary: | summary |