FDA.reportPublic FDA data

EvoEndo Model LE Single-Use Gastroscope

Primary DI
00850031897014
Brand
EvoEndo Model LE Single-Use Gastroscope
Company
Evoendo, Inc.
Model
LE
Catalog number
1001
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
2022-02-25
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
00850031897014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031897014008500318970148500318970140850031897014

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
Length1.1Meter
Lumen/Inner Diameter2Millimeter
Outer Diameter3.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure80 KiloPascal109 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850031897076Single-Use Gastroscope 3.5/2.0 85cmLE 10212024-08-30
00850031897083Single-Use Gastroscope 3.5/2.0 85cm 5-packLE10252024-08-30
00850031897090Single-Use Gastroscope 3.5/2.0 85cm DEMOLE10272024-08-30
00850031897021EvoEndo ControllerEE-C10022022-02-25
00850031897038EvoEndo Model LE Single-Use GastroscopeLE10052022-02-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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