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Series 400 Gastroenterology System

by Marks & Murase

510(k) K944620

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK944620 Date27 Apr 1995ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2778-2015 FDA Class II initiated 30 Jun 2015 on shared 510(k) K944620

    The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

    • Terminated Z-0708-06 FDA Unclassified (pre-2012) initiated 27 Mar 2006 on shared 510(k) K944620

    Colonoscope insertion tube is not bending properly and is stiff.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
FET
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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