K181838 is an FDA 510(k) clearance for the Sinusway Dilation System. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).
Submitted by 3nt Medical , Ltd. (Rosh Ha'Ayin, IL). The FDA issued a Cleared decision on December 20, 2018, 163 days after receiving the submission on July 10, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K181838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2018 |
| Decision Date | December 20, 2018 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LRC - Instrument, Ent Manual Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |