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INTRACORPOREAL ULTRASOUND LITHOTRIPTER - 2271.004

by Richard Wolf Medical Instruments Corp.

510(k) K011065

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK011065 Date9 May 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0081-04 FDA Unclassified (pre-2012) initiated 9 Oct 2003 on shared 510(k) K011065

    The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.

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  • Withdrawn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
Models / Variants
2271.004
Device Class
Class II
Regulation
21 CFR Part 876.4480
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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