EvoEndo Model LE Single-Use Gastroscope

FDA UDI

Class II (US FDA UDI)

by Evoendo, Inc.

Identity

Trade Name: EvoEndo Model LE Single-Use Gastroscope FDA UDI
Generic Name: Flexible video gastroscope, single-use FDA UDI
Device Name: 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 FDA UDI
Model / Reference: LE FDA UDI
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 FDA UDI

Identifiers

Catalog Number: 1001 FDA UDI
Primary DI / UDI-DI: 00850031897014 FDA UDI
510(k) Number: K213606 FDA UDI
FDA Product Code: FDS FDA UDI
GMDN Term: Flexible video gastroscope, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.5 Millimeter FDA UDI
Lumen/Inner Diameter — 2 Millimeter FDA UDI
Length — 1.1 Meter FDA UDI

Category: Flexible video gastroscope, single-use

EvoEndo Model LE Single-Use Gastroscope by Evoendo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video gastroscope, single-use.

Ambu® aScope™ Gastro Large — Ambu A/S · Class II
aScope™ Gastro — Ambu A/S · Class II
Single-Use Gastroscope 3.5/2.0 85cm 5-pack — Evoendo, Inc. · Class II
EvoEndo Model LE Single-Use Gastroscope — Evoendo, Inc. · Class II
Single-Use Gastroscope 3.5/2.0 85cm — Evoendo, Inc. · Class II
Single-Use Gastroscope 3.5/2.0 85cm DEMO — Evoendo, Inc. · Class II

Cleared under the same submission

K213606 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Evoendo, Inc.

Sources (1)

FDA UDI 49e8e2cf-6a08-4dc2-ae33-6c9653c0f5b4 37 fields · synced May 31, 2026