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Irrigation Pump, Irrigation Biopsy Valve, , Model 00711520, 00711139, 00711140

by United States Endoscopy Group, Inc.

510(k) K092461

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092461 Date5 Nov 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1943-2015 FDA Class II initiated 17 Feb 2015

    The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.

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  • Withdrawn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

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