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Pentax

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name
PENTAX FDA UDI
Generic Name
Flexible video gastroscope, reusable FDA UDI
Device Name
PENTAX VIDEO UPPER G.I.SCOPE EG-2990i FDA UDI
Model / Reference
EG-2990i FDA UDI
Description
PENTAX VIDEO UPPER G.I.SCOPE EG-2990i FDA UDI

Identifiers

Primary DI / UDI-DI
04961333254408 FDA UDI
510(k) Number
K131902 FDA UDI
FDA Product Code
FDS FDA UDI
GMDN Term
Flexible video gastroscope, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Category: Flexible video gastroscope, reusable

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

Similar devices

Also classified as Flexible video gastroscope, reusable.

Cleared under the same submission

K131902 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hoya Corporation

Sources (1)

  • FDA UDI c45271a3-c52d-4223-b84d-3f990aa69f99 34 fields · synced May 30, 2026