Ultrasound Bronchoscope

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: ULTRASOUND BRONCHOSCOPE FDA UDI
Generic Name: Flexible ultrasound bronchoscope FDA UDI
Device Name: LINEAR ULTRASOUND VIDEOBRONCHOSCOPE 2.0C (REFURBISHED) FDA UDI
Model / Reference: EB-1970UK FDA UDI
Description: LINEAR ULTRASOUND VIDEOBRONCHOSCOPE 2.0C (REFURBISHED) FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333232208 FDA UDI
510(k) Number: K131946 FDA UDI
FDA Product Code: EOQ FDA UDI
GMDN Term: Flexible ultrasound bronchoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4680 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 ultrasound bronchoscope

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

Similar devices

Also classified as Flexible ultrasound bronchoscope.

FUJIFILM — FUJIFILM Corporation · Class II
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
PENTAX Medical — HOYA CORPORATION · Class II
FUJIFILM — FUJIFILM Corporation · Class I
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
FUJIFILM — FUJIFILM Corporation · Class I
PENTAX Medical — HOYA CORPORATION · Class II
FUJIFILM — FUJIFILM Corporation · Class II

Cleared under the same submission

K131946 also covers:

PENTAX — 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 2a548897-aaf6-49f4-978d-ccd0f1f33ff1 34 fields · synced Jun 6, 2026