FDA.reportPublic FDA data

iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology

Primary DI
00853704002487
Brand
iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology
Company
GLAUKOS CORPORATION
Model
iS2
Catalog number
iS2
Device description
Trabecular Micro-Bypass System
Published
2025-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGOIntraocular Pressure Lowering Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGOIntraocular Pressure Lowering ImplantUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170043019

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170043019iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)Glaukos Corporation2018-06-21OGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853704002487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853704002487008537040024878537040024870853704002487

GMDN Terms#

Term, Definition table
TermDefinition
Glaucoma micro-stentA non-bioabsorbable device designed to be implanted in Schlemm’s canal (within the eye) for the restoration of aqueous humour outflow and subsequent reduction of intraocular pressure as part of treatment for open angle glaucoma. It is a metallic device which may be intended to dilate, support, and/or create a channel into Schlemm’s canal; disposable devices associated with implantation (e.g., delivery system) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012835406
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853704002456iPRIMEVCP100VCP1002022-05-13
00853704002449iStent InfiniteiS3iS3-US2022-10-19
00853704002470iStent infiniteiS3iS32022-10-05
00853704002319iStent inject WG2-WG2-W2020-08-11
00853704002005iStentGTS100RGTS100R2015-09-21
00853704002012iStentGTS100LGTS100L2015-09-21
00853704002029iStentGTS100iGTS100i2015-09-21
00853704002203iStent injectG2-M-ISG2-M-IS2018-07-25
00853704002463iAccessAX1AX12022-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853704002319iStent inject WGLAUKOS CORPORATIONOGO2020-08-11
00867487000134Hydrus® MicrostentAlcon Laboratories, Inc.OGO2018-08-15
20867487000138Hydrus® MicrostentIVANTIS, INC.OGO2018-08-15
00853704002203iStent injectGLAUKOS CORPORATIONOGO2018-07-25
00380657540075CypassAlcon Laboratories, Inc.OGO2018-07-19
00380657540037CyPassAlcon Laboratories, Inc.OGO2016-09-16
10380657540034CyPassAlcon Laboratories, Inc.OGO2016-09-16
00853704002005iStentGLAUKOS CORPORATIONOGO2015-09-21
00853704002012iStentGLAUKOS CORPORATIONOGO2015-09-21
00853704002029iStentGLAUKOS CORPORATIONOGO2015-09-21