Video Colonoscope

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: VIDEO COLONOSCOPE FDA UDI
Generic Name: Flexible video colonoscope, reusable FDA UDI
Device Name: HDVIDEO COLONOSCOPE 3.2C 11.6T 1700L FWJ (REFURBISHED) FDA UDI
Model / Reference: EC-3490LI FDA UDI
Description: HDVIDEO COLONOSCOPE 3.2C 11.6T 1700L FWJ (REFURBISHED) FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333232253 FDA UDI
510(k) Number: K131855 FDA UDI
FDA Product Code: FDF FDA UDI
GMDN Term: Flexible video colonoscope, reusable 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

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Flexible video colonoscope, reusable

Video Colonoscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video colonoscope, reusable.

PENTAX — HOYA CORPORATION · Class II
FUJIFILM — FUJIFILM Corporation · Class II
Endoch — Endoch Inc · Class II
PENTAX — HOYA CORPORATION · Class II
FUJIFILM — FUJIFILM Corporation · Class II
FUJIFILM — FUJIFILM Corporation · Class II
EVIS EXERA lll COLONOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
PENTAX Medical — HOYA CORPORATION · Class II

Cleared under the same submission

K131855 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: PENTAX of America, Inc.

Sources (1)

FDA UDI 2884cd20-6a5c-4e18-afa6-505173a598c1 34 fields · synced Jun 1, 2026