The following data is part of a premarket notification filed by Boston Scientific with the FDA for Orise Tissue Retractor System.
| Device ID | K173400 |
| 510k Number | K173400 |
| Device Name: | ORISE Tissue Retractor System |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Boston Scientific 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Thomas Hirte |
| Correspondent | Thomas Hirte Boston Scientific 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | FED |
| Subsequent Product Code | GAD |
| Subsequent Product Code | ODB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-31 |
| Decision Date | 2018-02-09 |
| Summary: | summary |