Company ยท US
Power Medical Interventions, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2009. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2009 | K091215 | INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT Power Medical Interventions, Inc. | GDW |
| Dec 18, 2008 | K083527 | INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS Power Medical Interventions, Inc. | GDW |
| Jul 25, 2008 | K081826 | INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V Power Medical Interventions, Inc. | GDW |
| Dec 18, 2007 | K073001 | IDRIVES, IDRIVEC, IDRIVEF Power Medical Interventions, Inc. | GDW |
| Dec 7, 2007 | K073148 | IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS Power Medical Interventions, Inc. | GDW |
| Sep 27, 2007 | K071708 | I45, I45S, I60, AND I60S Power Medical Interventions, Inc. | GDW |
| Jan 12, 2007 | K063746 | POWER EXTENDERS MODEL# PEC200, PES200,PES200S Power Medical Interventions, Inc. | GDW |
| Nov 2, 2006 | K063075 | NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS Power Medical Interventions, Inc. | GDW |
| Sep 1, 2006 | K061649 | POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH Power Medical Interventions, Inc. | GDW |
| Nov 7, 2005 | K052910 | POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS Power Medical Interventions, Inc. | GDW |
| Sep 29, 2005 | K052415 | POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS Power Medical Interventions, Inc. | GDW |
| Jun 3, 2004 | K040720 | SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM Power Medical Interventions, Inc. | GDW |
| Mar 24, 2004 | K040398 | SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS Power Medical Interventions, Inc. | GDW |
| Feb 4, 2004 | K040024 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29 Power Medical Interventions, Inc. | GDW |
| Sep 30, 2003 | K032701 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) Power Medical Interventions, Inc. | GDW |
| Mar 31, 2003 | K030653 | SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS Power Medical Interventions, Inc. | GDW |
| Dec 9, 2002 | K022313 | SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V Power Medical Interventions, Inc. | GDW |
| Jun 21, 2002 | K021701 | SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 Power Medical Interventions, Inc. | GDW |
| May 15, 2002 | K021249 | SURGASSIST FLEXSHAFT 2, MODEL FS2 14 Power Medical Interventions, Inc. | GDW |
| May 10, 2002 | K020719 | SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES Power Medical Interventions, Inc. | GDW |
| Apr 10, 2002 | K020343 | SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL Power Medical Interventions, Inc. | GDW |
| Oct 26, 2001 | K012809 | SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 Power Medical Interventions, Inc. | GDW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2007 | Power Medical Interventions, Inc Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60 Terminated |
GDW | K052415 |
| Dec 19, 2003 | Power Medical Interventions SurgAssist System Circular Stapler DLU 33mm Terminated |
GWD | K032701 |
| Dec 19, 2003 | Power Medical Interventions SurgAssist System Circular Stapler DLU 29mm Terminated |
GWD | K032701 |
| Jul 24, 2003 | Power Medical Interventions SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33). Terminated |
GAG | K003277 |
| Jul 24, 2003 | Power Medical Interventions SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29) Terminated |
GAG | K003277 |