FDA Product Code ORY: Tongue Suspension System
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.
Leading manufacturers include Siesta Medical, Inc..
10
Total
10
Cleared
114d
Avg days
2010
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Tongue Suspension System Devices (Product Code ORY)
10 devices
Cleared
Dec 22, 2021
Encore System
Siesta Medical, Inc.
Dental
85d
Cleared
Oct 02, 2020
Encore System
Siesta Medical, Inc.
Dental
148d
Cleared
May 09, 2019
Encore System
Siesta Medical, Inc.
Dental
161d
Cleared
Mar 26, 2014
ENCORE SYSTEM
Siesta Medical, Inc.
Dental
114d
Cleared
Dec 06, 2012
ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
Siesta Medical, Inc.
Dental
205d
Cleared
Nov 07, 2012
ENCORE TONGUE SUSPENSION SYSTEM
Siesta Medical, Inc.
Dental
140d
Cleared
Jul 01, 2011
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
Siesta Medical, Inc.
Dental
65d
Cleared
Apr 08, 2011
PRELUDE III TONGUE SUSPENSION SYSTEM
Siesta Medical, Inc.
Dental
80d
Cleared
Dec 20, 2010
PRELUDE II TOUNGE SUSPENSION SYSTEM
Siesta Medical, Inc.
Dental
53d
Cleared
Jul 08, 2010
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
Siesta Medical, Inc.
Dental
84d
About Product Code ORY - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code ORY since 2010, with 10 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.