Evoendo, Inc.

Address:12649 East Caley Avenue,Centennial,CO,80111,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Gastroscope And Accessories, Flexible/Rigid (FDS) (2) Endoscopic Video Imaging System/Component, Gastroenterology-Urology (FET) (1)

Premarket Exempt

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EvoEndo Model LE Single-Use Gastroscope - 00850031897014 Catalog Number : 1001

Device Description : The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform o 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

Device Class : 2

Duns Number: 117077970

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

EvoEndo Controller - 00850031897021 Catalog Number : 1002

Device Description : The Controller of the EvoEndo Endoscopy System translates the images or video ca The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable

Device Class : 2

Duns Number: 117077970

Premarket Exempt : No

Product Code : FET

Prescription Use : No

Device Count : 1

EvoEndo Model LE Single-Use Gastroscope - 00850031897038 Catalog Number : 1005

Device Class : 2

Duns Number: 117077970

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

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