Acmi Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061975PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PKAugust 10, 2006
K060752ACMI DUR-HL LASER SYSTEMSMay 25, 2006
K060269ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEMMarch 31, 2006
K051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224September 2, 2005
K052044ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6ALAugust 16, 2005
K043581DUAL LUMEN CATHETERMarch 3, 2005
K042069INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEMNovember 1, 2004
K042225ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565September 10, 2004
K031758ACMI M4 TELESCOPESSeptember 2, 2003
K030960ECN ELECTRONIC VIDEO CYSTONEPHROSCOPEJuly 16, 2003
K030935BERKELEY V-10 VACUUM CURETTAGE SYSTEMJune 23, 2003
K030684SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SHJune 3, 2003
K031001ACMI VISTA CTR BIPOLAR LOOP ELECTRODEMay 21, 2003
K023358USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8January 3, 2003
K022480ACMI DISPOSABLE BIPOLAR CORD, MODEL DBCAugust 22, 2002
K012018BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910July 16, 2002