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Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.XXX

by Richard Wolf Medical Instruments Corp.

510(k) K011911

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011911 Date17 Sep 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0537-04 FDA Unclassified (pre-2012) initiated 2 Feb 2004 on shared 510(k) K011911

    If the drain tube is assembled incorrectly, the suction pump will not operate as intended.

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  • Withdrawn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
FFK
Device Class
Class II
Regulation
21 CFR Part 876.4480
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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