ORY
10 FDA 510(k) clearances · Product code
114 daysmedian time to decision
205 days90th percentile
10clearances measured
FDA profile
- Official device name
- Tongue Suspension System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5570
- Medical specialty
- Dental
- Flags
- Implant
- FDA 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.
- Adverse events (MAUDE)
- 2014: 9 · 2023: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Encore System (K213159) | Siesta Medical, Inc. | 2021-12-22 |
| Encore System (K201238) | Siesta Medical, Inc. | 2020-10-02 |
| Encore System (K183310) | Siesta Medical, Inc. | 2019-05-09 |
| ENCORE SYSTEM (K133680) | Siesta Medical, Inc. | 2014-03-26 |
| ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT (K121440) | Siesta Medical, Inc. | 2012-12-06 |
| ENCORE TONGUE SUSPENSION SYSTEM (K121814) | Siesta Medical, Inc. | 2012-11-07 |
| ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN (K111179) | Siesta Medical, Inc. | 2011-07-01 |
| PRELUDE III TONGUE SUSPENSION SYSTEM (K110127) | Siesta Medical, Inc. | 2011-04-08 |
| PRELUDE II TOUNGE SUSPENSION SYSTEM (K103179) | Siesta Medical, Inc. | 2010-12-20 |
| SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM (K101060) | Siesta Medical, Inc. | 2010-07-08 |
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Every clearance here is in the API, with alerts when new ones post.