Pentax

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name: PENTAX FDA UDI
Generic Name: Endoscopic device remote control FDA UDI
Device Name: KEYBOARD FOR EPK-1000 FDA UDI
Model / Reference: OS-A50 FDA UDI
Description: KEYBOARD FOR EPK-1000 FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333169061 FDA UDI
510(k) Number: K934918 FDA UDI
FDA Product Code: FET FDA UDI
GMDN Term: Endoscopic device remote control 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic device remote control

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

Similar devices

Also classified as Endoscopic device remote control.

REMOTE CONTROL — Olympus Medical Systems Corporation · Class II
Imaging (ZEOS) — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
ENDOCAM — Richard Wolf GmbH · Class II
DYONICS 25 — Smith & Nephew, Inc. · Class II
Connected OR HUB — Stryker Corp. · Class II
OBCU REMOTE CONTROLLER — Olympus Medical Systems Corporation · Class II
Connected OR HUB — Stryker Corp. · Class II
Trinity — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II

Cleared under the same submission

K934918 also covers:

PENTAX — HOYA CORPORATION
PENTAX — HOYA CORPORATION
VIDEO PROCESSOR — PENTAX of America, Inc.
VIDEO PROCESSOR — PENTAX of America, Inc.
VIDEO PROCESSOR — 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

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Manufacturer

Manufacturer: Hoya Corporation

Sources (1)

FDA UDI b69b11a3-a357-4093-a07b-c27dcd7acd70 34 fields · synced May 30, 2026