K201238 is an FDA 510(k) clearance for the Encore System. This device is classified as a Tongue Suspension System (Class II - Special Controls, product code ORY).
Submitted by Siesta Medical, Inc. (Los Gatos, US). The FDA issued a Cleared decision on October 2, 2020, 148 days after receiving the submission on May 7, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570. Intended To Be Used For Anterior Advancement Of The Tongue Base By Means Of A Bone Screw Threaded With A Suture. It Is Indicated For The Treatment Of Obstructive Sleep Apnea (osa) And/or Snoring..
| 510(k) Number | K201238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2020 |
| Decision Date | October 02, 2020 |
| Days to Decision | 148 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ORY - Tongue Suspension System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
| Definition | Intended To Be Used For Anterior Advancement Of The Tongue Base By Means Of A Bone Screw Threaded With A Suture. It Is Indicated For The Treatment Of Obstructive Sleep Apnea (osa) And/or Snoring. |