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Enteroscope

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
ENTEROSCOPE FDA UDI
Generic Name
Flexible video enteroscope FDA UDI
Device Name
SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ (REFURBISHED) FDA UDI
Model / Reference
VSB-3430K FDA UDI
Description
SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ (REFURBISHED) FDA UDI

Identifiers

Primary DI / UDI-DI
04961333232925 FDA UDI
510(k) Number
K962897 FDA UDI
FDA Product Code
FDS FDA UDI
GMDN Term
Flexible video enteroscope 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 enteroscope

Enteroscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video enteroscope.

Cleared under the same submission

K962897 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 72cd9915-995c-468a-97e2-8a3f592d07e6 34 fields · synced Jun 1, 2026