Fiber Bronchoscope

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: FIBER BRONCHOSCOPE FDA UDI
Generic Name: Flexible fibreoptic bronchoscope FDA UDI
Device Name: FIBEROPTIC BRONCHOSCOPE 2.8C 5.9TP 600L (REFURBISHED) FDA UDI
Model / Reference: FB-18V FDA UDI
Description: FIBEROPTIC BRONCHOSCOPE 2.8C 5.9TP 600L (REFURBISHED) FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333232680 FDA UDI
510(k) Number: K951199 FDA UDI
FDA Product Code: EOQ FDA UDI
GMDN Term: Flexible fibreoptic 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 fibreoptic bronchoscope

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

Similar devices

Also classified as Flexible fibreoptic bronchoscope.

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE N20 — Olympus Medical Systems Corporation · Class II
OES BRONCHOFIBERSCOPE — Olympus Medical Systems Corporation · Class II
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
PENTAX — HOYA CORPORATION · Class II
PENTAX — HOYA CORPORATION · Class II
FIBER BRONCHOSCOPE — PENTAX of America, Inc. · Class II
FIBER BRONCHOSCOPE — PENTAX of America, Inc. · Class II
FIBER BRONCHOSCOPE — PENTAX of America, Inc. · Class II

Cleared under the same submission

K951199 also covers:

PENTAX — HOYA CORPORATION
PENTAX — HOYA CORPORATION
PENTAX — HOYA CORPORATION
PENTAX — HOYA CORPORATION
PENTAX — HOYA CORPORATION
FIBER BRONCHOSCOPE — PENTAX of America, Inc.
FIBER BRONCHOSCOPE — PENTAX of America, Inc.

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

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

Manufacturer

Manufacturer: PENTAX of America, Inc.

Sources (1)

FDA UDI 44606bf0-2157-4a4f-b13a-dd2e06664ed3 34 fields · synced Jun 8, 2026