Medical Device Manufacturer · US , Southborough , MA

Acmi Corporation

16 submissions · 16 cleared · Since 2002
16
Total
16
Cleared
0
Denied

Acmi Corporation — FDA 510(k) Submissions

Acmi Corporation has submitted 16 FDA 510(k) premarket notifications since 2002, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Cystoscope And Accessories, Flexible/rigid, Electrosurgical, Cutting & Coagulation & Accessories, Ureteroscope And Accessories, Flexible/rigid, Endoscopic Storage Cover, System, Abortion, Vacuum . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK
K061975 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 2006 28d
ACMI DUR-HL LASER SYSTEMS
K060752 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 2006 65d
ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
K060269 · FBN Choledochoscope And... · Gastroenterology & Urology
Mar 2006 58d
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
K051593 · KNY Accessories, Catheter, G-u · Gastroenterology & Urology
Sep 2005 78d
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
K052044 · FGB Ureteroscope And... · Gastroenterology & Urology
Aug 2005 19d
DUAL LUMEN CATHETER
K043581 · EYB Catheter, Ureteral,... · Gastroenterology & Urology
Mar 2005 65d
INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
K042069 · GCJ Laparoscope, General &... · General & Plastic Surgery
Nov 2004 91d
ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K042225 · FAJ Cystoscope And... · Gastroenterology & Urology
Sep 2004 24d
ACMI M4 TELESCOPES
K031758 · FBP Telescope, Rigid, Endoscopic · Gastroenterology & Urology
Sep 2003 88d
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
K030960 · FAJ Cystoscope And... · Gastroenterology & Urology
Jul 2003 111d
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
K030935 · HHI System, Abortion, Vacuum · Obstetrics & Gynecology
Jun 2003 90d
SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH
K030684 · OCU Endoscopic Storage Cover · Gastroenterology & Urology
Jun 2003 90d
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
K031001 · FAS Electrode,... · Gastroenterology & Urology
May 2003 51d
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
K023358 · FGB Ureteroscope And... · Gastroenterology & Urology
Jan 2003 88d
ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
K022480 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Aug 2002 27d
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
K012018 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2002 383d
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