510(k) K133680
K133680 is an FDA 510(k) premarket notification submitted by Siesta Medical, Inc. for the device "ENCORE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 26, 2014. The device falls under product code ORY (Tongue Suspension System), a Class II device regulated under 21 CFR 872.5570. Siesta Medical, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2014
- Date Received
- December 2, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tongue Suspension System
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
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.