Aeh-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F)

• 4 recalls, same reason

  • Terminated Z-0928-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0927-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0926-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0925-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004

  Product sterility may be compromised due to the lack of package seal integrity

510(k) Number

K980492 ↗

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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See all devices from Circon Acmi →