510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183310Substantially Equivalent

Encore System

Siesta Medical, Inc., Los Gatos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183310 is the FDA 510(k) clearance record for Encore System, a class II device, cleared for Siesta Medical, Inc. on under FDA product code ORY (Tongue Suspension System). FDA's definition for product code ORY reads: "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". FDA records list 10 510(k) clearances for Siesta Medical, Inc., from to . As of , FDA records show no recalls naming K183310.

Clearance record

Decision date
Received
(161 days to decision)
Product code
ORY Tongue Suspension System
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Siesta Medical, Inc. 101 Church St., Suite 3, Los Gatos CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORY

Trailing 12 months

FDA records hold no clearances under product code ORY in the trailing twelve months.

FDA records show no clearances under product code ORY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ORY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260