Pentax

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name: PENTAX FDA UDI
Generic Name: Flexible fibreoptic nasopharyngolaryngoscope FDA UDI
Device Name: NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES FDA UDI
Model / Reference: FNL-10RP3 FDA UDI
Description: NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333224258 FDA UDI
510(k) Number: K951196 FDA UDI
FDA Product Code: EOB FDA UDI
GMDN Term: Flexible fibreoptic nasopharyngolaryngoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4760 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

Yes

FDA UDI

Category: Flexible fibreoptic nasopharyngolaryngoscope

Pentax by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic nasopharyngolaryngoscope.

FIBER LARYNGOSCOPE — PENTAX of America, Inc. · Class II
FIBER NASO PHARYNGO LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class II
RHINO-LARYNGO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
Henke-Sass Wolf — H & A Mui Enterprises Inc · Class II
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
FIBER LARYNGOSCOPE — PENTAX of America, Inc. · Class II
RHINO-LARYNGO FIBERSCOPE — Olympus Medical Systems Corporation · Class II

Cleared under the same submission

K951196 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: Hoya Corporation

Sources (1)

FDA UDI d3b1c35d-88fa-4d0c-b0d9-88d9c381e296 34 fields · synced Jun 8, 2026