Pentax

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name: PENTAX FDA UDI
Generic Name: Flexible video laryngoscope FDA UDI
Device Name: VNL-1570STK VIDEO ENTSCOPE FDA UDI
Model / Reference: VNL-1570STK FDA UDI
Description: VNL-1570STK VIDEO ENTSCOPE FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333233809 FDA UDI
510(k) Number: K162151 FDA UDI
FDA Product Code: EOB FDA UDI
GMDN Term: Flexible video laryngoscope 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 video laryngoscope

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

Similar devices

Also classified as Flexible video laryngoscope.

PEMF - PHYSIO-STIM — Orthofix US LLC · Class II
PEMF - PHYSIO-STIM — Orthofix US LLC · Class II
PEMF - CERVICAL-STIM — Orthofix US LLC · Class II
PEMF - CERVICAL-STIM — Orthofix US LLC · Class III
RHINO-LARYNGO VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
PEMF - PHYSIO-STIM — Orthofix US LLC · Class III
SourceMark — SOURCEMARK, LLC. · Class I
PEMF - PHYSIO-STIM — Orthofix US LLC · Class III

Cleared under the same submission

K162151 also covers:

VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE — 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: Hoya Corporation

Sources (1)

FDA UDI a4e69f91-6f8b-4edf-af5d-6bed0bb0b3c5 34 fields · synced May 30, 2026