Berkeley V-10 Vacuum Curettage System

• • Ongoing Z-0159-2020 FDA Class II ·initiated 12 Sep 2019

  Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate

510(k) Number

K030935 ↗

FDA Product Code

HHI

Device Class

Class II

Regulation

21 CFR Part 884.5070

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Dual Lumen Catheter

  Class II

  FDA 510(k) K043581 Active Cleared 3 Mar 2005

• Uropass Ureteral Access Sheath, Model 61224 Open recall

  Class II

  FDA 510(k) K051593 Active Cleared 2 Sep 2005

• USA Series Dur 8 Elite, USA Series Dur 8, Models Dur 8E, Dur 8

  Class II

  FDA 510(k) K023358 Active Cleared 3 Jan 2003

• Acmi Dur-Digital Ureteroscope and Choledochoscope System

  Class II

  FDA 510(k) K060269 Active Cleared 31 Mar 2006

• Ecn Electronic Video Cystonephroscope

  Class II

  FDA 510(k) K030960 Active Cleared 16 Jul 2003

• Acmi Disposable Bipolar Cord, Model Dbc

  Class II

  FDA 510(k) K022480 Active Cleared 22 Aug 2002

See all devices from Acmi Corporation →