← Back to catalogue

Endoeye Flex Deflectable Videoscope

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FDA UDI
Generic Name
Rigid video laparoscope FDA UDI
Model / Reference
OLYMPUS LTF-S190-5 FDA UDI

Identifiers

Catalog Number
N3828033 FDA UDI
Primary DI / UDI-DI
04953170434648 FDA UDI
510(k) Number
K201832 FDA UDI
FDA Product Code
HET FDA UDI
GMDN Term
Rigid video laparoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

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 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

K201832 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI ae9eb131-c1de-4c6d-82be-5d0c126d5e1b 35 fields · synced Jun 1, 2026