The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Xpress Multi-sinus Dilation Tool.
| Device ID | K121174 |
| 510k Number | K121174 |
| Device Name: | XPRESS MULTI-SINUS DILATION TOOL |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Entellus Medical, Inc. 6705 WEDGWOOD COURT NORTH Maple Grove, MN 55311 |
| Contact | Karen E Peterson |
| Correspondent | Karen E Peterson Entellus Medical, Inc. 6705 WEDGWOOD COURT NORTH Maple Grove, MN 55311 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-17 |
| Decision Date | 2012-05-17 |
| Summary: | summary |