FDA.reportPublic FDA data

Encore System

Primary DI
00862211000206
Brand
Encore System
Company
Siesta Medical
Model
FG0002
Device description
Implants and delivery tools for hyoid and tongue suspension.
Published
2015-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ORYPrelude Tongue Suspension System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORYTongue Suspension SystemDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133680000ENCORE SYSTEMSiesta Medical, Inc.2014-03-26ORY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862211000206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862211000206008622110002068622110002060862211000206

GMDN Terms#

Term, Definition table
TermDefinition
Sleep apnoea tongue implant, non-bioabsorbableA sterile device intended to be implanted into the tongue to help increase airway patency by anterior advancement and physical stabilization of the tongue in the management of obstructive sleep apnoea (OSA). It is in the form of a non-bioabsorbable looped thread implanted in the base of the tongue, attached anteriorly to the mandible with a bone anchor. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
940968808
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862211000213RevolutionFG00082018-04-16
00862211000220Encore Revision KitFG00052019-06-17