ORY — Tongue Suspension System Class II
FDA product code ORY covers "Tongue Suspension System", a Class II medical device regulated under 21 CFR 872.5570. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ORY
- Device Class
- Class II
- Regulation Number
- 872.5570
- Submission Type
- 510(k)
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213159 | Siesta Medical | Encore System | Dec 22, 2021 |
| K201238 | Siesta Medical | Encore System | Oct 2, 2020 |
| K183310 | Siesta Medical | Encore System | May 9, 2019 |
| K133680 | Siesta Medical | ENCORE SYSTEM | Mar 26, 2014 |
| K121440 | Siesta Medical | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | Dec 6, 2012 |
| K121814 | Siesta Medical | ENCORE TONGUE SUSPENSION SYSTEM | Nov 7, 2012 |
| K111179 | Siesta Medical | ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE… | Jul 1, 2011 |
| K110127 | Siesta Medical | PRELUDE III TONGUE SUSPENSION SYSTEM | Apr 8, 2011 |
| K103179 | Siesta Medical | PRELUDE II TOUNGE SUSPENSION SYSTEM | Dec 20, 2010 |
| K101060 | Siesta Medical | SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM | Jul 8, 2010 |