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Pentax ED-3490TK Video Duodenoscope

by Pentax Medical Company

510(k) K092710

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092710 Date2 Dec 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0643-2018 FDA Class II initiated 13 Feb 2018

    The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.

    • Terminated Z-2713-2017 FDA Class II initiated 17 Jan 2017

    Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FDT
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pentax Ed-3490Tk Video Duodenoscope is a duodenoscope, a type of flexible or rigid endoscope used in gastroenterology and urology. It is designed to provide visualization and access for diagnostic and therapeutic procedures, such as Endoscopic Retrograde Cholangiopancreatography (ERCP). The device has an 11.6mm diameter and a 4.2mm instrument channel.

The Pentax Ed-3490Tk Video Duodenoscope is supplied with an insertion tube diameter of 11.6mm and an instrument channel of 4.2mm. It is used in medical settings for procedures such as ERCP, and is subject to regulatory authorizations, including FDA 510K clearance. The device is classified as a Class 2 device, with a regulation number of 876.1500.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Pentax ED-3490TK used for?

    The Pentax ED-3490TK is used for diagnostic and therapeutic procedures such as Endoscopic Retrograde Cholangiopancreatography (ERCP) in gastroenterology and urology.

  • What are the key specifications of the Pentax ED-3490TK?

    The device has an 11.6mm diameter and a 4.2mm instrument channel, and is supplied with an insertion tube of the same diameter and instrument channel size.

  • Is the Pentax ED-3490TK subject to regulatory authorizations?

    Yes, the Pentax ED-3490TK is subject to regulatory authorizations, including FDA 510K clearance, and is classified as a Class 2 device with a regulation number of 876.1500.

  • What medical specialties use the Pentax ED-3490TK?

    The Pentax ED-3490TK is used in gastroenterology and urology medical settings for procedures such as ERCP.