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Evis Exera Ii Ultrasound Gastrovideoscope

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE FDA UDI
Generic Name
Flexible ultrasound gastroduodenoscope FDA UDI
Device Name
GF-UCT180 Curvilinear EUS scope, 3.7 mm FDA UDI
Model / Reference
OLYMPUS GF TYPE UCT180 FDA UDI
Description
GF-UCT180 Curvilinear EUS scope, 3.7 mm FDA UDI

Identifiers

Primary DI / UDI-DI
04953170356339 FDA UDI
510(k) Number
K093395 FDA UDI
FDA Product Code
IYO FDA UDI
ODG FDA UDI
NWB FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term
Flexible ultrasound gastroduodenoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
876.1500 FDA UDI
892.1550 FDA UDI
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible ultrasound gastroduodenoscope

Evis Exera Ii Ultrasound Gastrovideoscope by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible ultrasound gastroduodenoscope.

Cleared under the same submission

K093395 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI ad1dcd65-5df0-4dfa-929d-3a73be3529d7 35 fields · synced May 30, 2026