FDA.reportPublic FDA data

Orbera™

Primary DI
00191506049232
Brand
Orbera™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00505670
Catalog number
M00505670
Device description
Endoscopic Suturing System
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LTIIMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTIImplant, Intragastric For Morbid ObesityUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140008028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140008028ORBERA INTRAGASTRIC BALLOONBoston Scientific Corporation2015-08-05LTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506049232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506049232001915060492321915060492320191506049232

GMDN Terms#

Term, Definition table
TermDefinition
Appetite-suppression gastric balloonAn implantable device intended to be swallowed or endoscopically inserted into the stomach where it is inflated to reduce stomach volume and facilitate weight loss in overweight/obese patients by restricting the quantity of food consumed through an increased sense of satiety (fullness). It is designed to be inflated/filled with an inert material (e.g., saline, air, nitrogen) in situ, where it remains until it is endoscopically removed or deflates and passes through the bowels. Disposable devices dedicated to introduction/inflation may be included with the balloon.

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010540119Allurion™ Gastric Balloon SystemAllurion Technologies, Inc.LTI2026-04-07
00810010540126Allurion™ Filler KitAllurion Technologies, Inc.LTI2026-04-07
00810010540133Allurion™ StyletAllurion Technologies, Inc.LTI2026-04-07
03665039001663Endoline PUNCPRINCE MEDICALLTI2024-01-30
03665039005630Extraction Kit PRINCE MEDICALLTI2024-01-30
00850007764500ReShape Lap-Band® 2.0 FLEX, StandardMedtimo, IncLTI2024-01-22
00850007764517ReShape Lap-Band® 2.0 FLEX, LargeMedtimo, IncLTI2024-01-22
00850007764548ReShape Lap-Band® 2.0, FLEX & Access Port, StandardMedtimo, IncLTI2024-01-22
00850007764555ReShape Lap-Band® 2.0, FLEX & Access Port, LargeMedtimo, IncLTI2024-01-22
00850007764586ReShape Lap-Band® 2.0, FLEX Tubing KitMedtimo, IncLTI2024-01-22
00860005178803Spatz3 Adjustable Balloon System insertion kit SPATZ FGIA (ISRAEL) LTDLTI2021-10-20
10850007764323LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)Medtimo, IncLTI2021-04-01
10850007764330LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)Medtimo, IncLTI2021-04-01
00850007764043RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System StandardMedtimo, IncLTI2021-02-01
00850007764067RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System LargeMedtimo, IncLTI2021-02-01
00850007764609LAP-BAND® AP System Standard with RapidPort® EZ Medtimo, IncLTI2021-02-01
00850007764654LAP-BAND® AP System Large with RapidPort® EZ Medtimo, IncLTI2021-02-01
00850007764906RapidPort® EZ Port ApplierMedtimo, IncLTI2021-01-01
00850007764173LAP-BAND® System Calibration TubeReShape Lifesciences Inc.LTI2020-12-01
00859810006227OBALON®Medtimo, IncLTI2019-02-20
00859810006104OBALON Touch™ Medtimo, IncLTI2019-02-20
00859810006142OBALON®Medtimo, IncLTI2019-02-20
00859810006173OBALON®Medtimo, IncLTI2019-02-20
00859810006180OBALON®Medtimo, IncLTI2019-02-20
00859810006197OBALON®Medtimo, IncLTI2019-02-20
00859810006203OBALON Touch™Medtimo, IncLTI2019-02-20
10859810006224OBALON®OBALON THERAPEUTICS, INC.LTI2019-02-20
00859810006234OBALON®Medtimo, IncLTI2019-02-20
00859810006241OBALON®Medtimo, IncLTI2019-02-20
00859810006210OBALON® Inflation CanMedtimo, IncLTI2018-07-11