Acmi Corporation
Medical device manufacturer in Southborough, MA.
16510(k) clearances
0PMA approvals
0recalls
Device types
- GEI Electrosurgical, Cutting & Coagulation &… 2
- FGB Ureteroscope And Accessories, Flexible/Rigid 2
- FAJ Cystoscope And Accessories, Flexible/Rigid 2
- HIH Hysteroscope (And Accessories) 1
- FAS Electrode, Electrosurgical, Active… 1
- OCU Endoscopic Storage Cover 1
- HHI System, Abortion, Vacuum 1
- FBP Telescope, Rigid, Endoscopic 1
- GCJ Laparoscope, General & Plastic Surgery 1
- EYB Catheter, Ureteral, Gastro-Urology 1
- KNY Accessories, Catheter, G-U 1
- FBN Choledochoscope And Accessories… 1
- GEX Powered Laser Surgical Instrument 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K061975 | Plasmaseal Open Forceps, Models 2103PK and 91701PKGEI · Special | 08/10/2006SE |
| K060752 | Acmi Dur-Hl Laser SystemsGEX · Traditional | 05/25/2006SE |
| K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemFBN · Traditional | 03/31/2006SE |
| K051593 | Uropass Ureteral Access Sheath, Model 61224KNY · Traditional | 09/02/2005SE |
| K052044 | Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALFGB · Special | 08/16/2005SE |
| K043581 | Dual Lumen CatheterEYB · Special | 03/03/2005SE |
| K042069 | Invisio Irl Digital Rigid Laparoscope SystemGCJ · Traditional | 11/01/2004SE |
| K042225 | Acmi Invisio Icn, Models ICN-0564 and ICN-0565FAJ · Special | 09/10/2004SE |
| K031758 | Acmi M4 TelescopesFBP · Traditional | 09/02/2003SE |
| K030960 | Ecn Electronic Video CystonephroscopeFAJ · Traditional | 07/16/2003SE |
| K030935 | Berkeley V-10 Vacuum Curettage SystemHHI · Traditional | 06/23/2003SE |
| K030684 | Scope Guard Protective Sheath, Model Tel-ShOCU · Traditional | 06/03/2003SE |
| K031001 | Acmi Vista CTR Bipolar Loop ElectrodeFAS · Special | 05/21/2003SE |
| K023358 | USA Series Dur 8 Elite, USA Series Dur 8, Models Dur 8E, Dur 8FGB · Traditional | 01/03/2003SE |
| K022480 | Acmi Disposable Bipolar Cord, Model DBCHIH · Special | 08/22/2002SE |
| K012018 | Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910GEI · Traditional | 07/16/2002SE |