The following data is part of a premarket notification filed by Nxthera (a Boston Scientific Company) with the FDA for Rezum Delivery Device, Rezum Generator.
| Device ID | K190093 |
| 510k Number | K190093 |
| Device Name: | Rezum Delivery Device, Rezum Generator |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | NxThera (A Boston Scientific Company) 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Justin Kapitan |
| Correspondent | Justin Kapitan NxThera (A Boston Scientific Company) 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-18 |
| Decision Date | 2019-03-25 |