Video Cytoscope

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: VIDEO CYTOSCOPE FDA UDI
Generic Name: Flexible video cystoscope, reusable FDA UDI
Device Name: VIDEO CYSTOSCOPE 2.0C 5.5TP 400L (REFURBISHED) FDA UDI
Model / Reference: ECY-1570K FDA UDI
Description: VIDEO CYSTOSCOPE 2.0C 5.5TP 400L (REFURBISHED) FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333232406 FDA UDI
510(k) Number: K914008 FDA UDI
FDA Product Code: FAJ FDA UDI
GMDN Term: Flexible video cystoscope, 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 cystoscope, reusable

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

Similar devices

Also classified as Flexible video cystoscope, reusable.

HD-VIEW — Karl Storz GmbH & Co. KG · Class II
Flexible Video Cystoscope (NTSC) — COGENTIX MEDICAL, INC. · Class II
Flexible Video Cystoscope (NTSC) Intuitive — COGENTIX MEDICAL, INC. · Class II
LUMINELLE DTx Hysteroscopy System — Uvision360, Inc. · Class II
C-VIEW — Karl Storz GmbH & Co. KG · Class II
MAMBA VISION — Richard Wolf GmbH · Class II
DirectVision — Percuvision, LLC · Class II
Luminelle DTx Control Hub — Uvision360, Inc. · Class II

Cleared under the same submission

K914008 also covers:

PENTAX Medical — HOYA CORPORATION

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 e67522fb-37d2-4e11-88f8-5cb48d806b26 34 fields · synced May 30, 2026