K152660 is an FDA 510(k) clearance for the HYPNOSPAD. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Somnics, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on November 9, 2016, 419 days after receiving the submission on September 17, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K152660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2015 |
| Decision Date | November 09, 2016 |
| Days to Decision | 419 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |