The following data is part of a premarket notification filed by Nxthera, Inc. with the FDA for Rezum System.
| Device ID | K160417 |
| 510k Number | K160417 |
| Device Name: | Rezum System |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | NxThera, Inc. 7351 Kirkwood Lane N, Suite 138 Maple Grove, MN 55369 |
| Contact | J. Robert Paulson |
| Correspondent | Julie Bodmer Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-03-17 |
| Summary: | summary |