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Video Sigmoidoscope

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
VIDEO SIGMOIDOSCOPE FDA UDI
Generic Name
Flexible video gastroscope, reusable FDA UDI
Device Name
VIDEO SIGMOIDOSCOPE 4.2C 12.8T 700L FWJ (REFURBISHED) FDA UDI
Model / Reference
ES-3870K FDA UDI
Description
VIDEO SIGMOIDOSCOPE 4.2C 12.8T 700L FWJ (REFURBISHED) FDA UDI

Identifiers

Primary DI / UDI-DI
04961333232642 FDA UDI
510(k) Number
K951577 FDA UDI
FDA Product Code
FAM 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

No

FDA UDI

Category: Flexible video gastroscope, reusable

Video Sigmoidoscope by PENTAX of America, Inc. — 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

K951577 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PENTAX of America, Inc.

Sources (1)

  • FDA UDI 74c1695c-9c1f-4572-930c-9b60ffbcbba1 34 fields · synced Jun 8, 2026