FDA.reportPublic FDA data

Single-Use Gastroscope 3.5/2.0 85cm 5-pack

Primary DI
00850031897083
Brand
Single-Use Gastroscope 3.5/2.0 85cm 5-pack
Company
Evoendo, Inc.
Model
LE
Catalog number
1025
Device description
The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of: - Handle - Umbilical Bundle that includes air, water, and suction lines, as well as the video connector - Endoscope shaft with HD Camera
Published
2024-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213606000EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.2022-02-14FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850031897083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031897083008500318970838500318970830850031897083

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video gastroscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length85Centimeter
Lumen/Inner Diameter2Millimeter
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117077970
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850031897076Single-Use Gastroscope 3.5/2.0 85cmLE 10212024-08-30
00850031897090Single-Use Gastroscope 3.5/2.0 85cm DEMOLE10272024-08-30
00850031897014EvoEndo Model LE Single-Use GastroscopeLE10012022-02-25
00850031897021EvoEndo ControllerEE-C10022022-02-25
00850031897038EvoEndo Model LE Single-Use GastroscopeLE10052022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDS2026-10-16
08809882470220Articulated Basic Gripper GEndoRobotics Co., Ltd.FDS2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDS2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDS2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDS2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDS2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDS2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDS2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDS2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDS2026-10-16
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