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Endoeye Flex 3d Deflectable Videoscope

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE FDA UDI
Generic Name
Rigid video laparoscope FDA UDI
Model / Reference
OLYMPUS LTF-190-10-3D FDA UDI

Identifiers

Primary DI / UDI-DI
04953170340710 FDA UDI
510(k) Number
K123365 FDA UDI
FDA Product Code
GCJ FDA UDI
HET FDA UDI
FGB FDA UDI
NWB FDA UDI
GMDN Term
Rigid video laparoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
884.1720 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: Rigid video laparoscope

Endoeye Flex 3d Deflectable Videoscope by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid video laparoscope.

Cleared under the same submission

K123365 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 5a9d00d4-94ee-47b5-86fc-e31d942aaba7 34 fields · synced May 30, 2026