Acmi Autoclavable Ureteroscope, Models Mr-6A and Mr-6AL

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K052044 ↗

FDA Product Code

FGB

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Dual Lumen Catheter

  Class II

  FDA 510(k) K043581 Active Cleared 3 Mar 2005

• Berkeley V-10 Vacuum Curettage System Open recall

  Class II

  FDA 510(k) K030935 Active Cleared 23 Jun 2003

• 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

See all devices from Acmi Corporation →