Encore System
Implants and delivery tools for hyoid and tongue suspension.
1manufacturer
1catalogue number
10510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Siesta Medical, Inc., United States |
|---|---|
| FDA product code | ORY |
| Device type | Tongue Suspension System |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-12-07 |
| Record revised | 2026-05-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG0002 | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213159 | 2021-12-22 |
| K201238 | 2020-10-02 |
| K183310 | 2019-05-09 |
| K133680 | 2014-03-26 |
| K121440 | 2012-12-06 |
| K121814 | 2012-11-07 |
| K111179 | 2011-07-01 |
| K110127 | 2011-04-08 |
| K103179 | 2010-12-20 |
| K101060 | 2010-07-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.