510(k) K101060
K101060 is an FDA 510(k) premarket notification submitted by Siesta Medical, Inc. for the device "SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 8, 2010. The device falls under product code ORY (Tongue Suspension System), a Class II device regulated under 21 CFR 872.5570. Siesta Medical, Inc. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 8, 2010
- Date Received
- Apr 15, 2010
- 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
- 510(k)
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.