Power Medical Interventions, Inc.
New Hope, PA, US
Power Medical Interventions, Inc. appears in FDA device records in New Hope, PA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for Power Medical Interventions, Inc. between 2001 and 2009. The busiest year on record is 2002, with 5. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 5 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091215 | INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT | GDW | Substantially Equivalent | |
| K083527 | INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS | GDW | Substantially Equivalent | |
| K081826 | INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V | GDW | Substantially Equivalent | |
| K073001 | IDRIVES, IDRIVEC, IDRIVEF | GDW | Substantially Equivalent | |
| K073148 | IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS | GDW | Substantially Equivalent | |
| K071708 | I45, I45S, I60, AND I60S | GDW | Substantially Equivalent | |
| K063746 | POWER EXTENDERS MODEL# PEC200, PES200,PES200S | GDW | Substantially Equivalent | |
| K063075 | NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS | GDW | Substantially Equivalent | |
| K061649 | POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH | GDW | Substantially Equivalent | |
| K052910 | POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS | GDW | Substantially Equivalent | |
| K052415 | POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS | GDW | Substantially Equivalent | |
| K040720 | SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM | GDW | Substantially Equivalent | |
| K040398 | SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS | GDW | Substantially Equivalent | |
| K040024 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29 | GDW | Substantially Equivalent | |
| K032701 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) | GDW | Substantially Equivalent | |
| K030653 | SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS | GDW | Substantially Equivalent | |
| K022313 | SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V | GDW | Substantially Equivalent | |
| K021701 | SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 | GDW | Substantially Equivalent | |
| K021249 | SURGASSIST FLEXSHAFT 2, MODEL FS2 14 | GDW | Substantially Equivalent | |
| K020719 | SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES | GDW | Substantially Equivalent | |
| K020343 | SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL | GDW | Substantially Equivalent | |
| K012809 | SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 | GDW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1099-2007 | Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60 | Malfunction - improper staple formation | Terminated | ||
| Z-0253-04 | SurgAssist System Circular Stapler DLU 33mm | improper staple formation or anvil jam | Terminated | ||
| Z-0252-04 | SurgAssist System Circular Stapler DLU 29mm | improper staple formation or anvil jam | Terminated | ||
| Z-1049-03 | SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33). | latching mechanism failure | Terminated | ||
| Z-1048-03 | SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29) | latching mechanism failure | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain