510(k) Report

FDA applicant

Power Medical Interventions, Inc.

Langhorne, PA22 decisions2001–200915 recalls

FDA records 22 decisions for Power Medical Interventions, Inc. (Langhorne, PA) from 2001 to 2009: 22 510(k) clearances. All are in product code GDW (Staple, Implantable). Its devices cite 44 predicates, 28 of them its own earlier devices. 15 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Power Medical Interventions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 42008: 22009: 1
2007high 4 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

12in 2009

2007: 12009: 12
2007high 12 (2009) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Power Medical Interventions, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Power Medical Interventions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GDWStaple, Implantable22decisions

Whose devices does it build on?

Its devices cite 44 predicates; 28 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 28 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 20076cite it
  • K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc. · 20016cite it
  • K021701Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60Power Medical Interventions, Inc. · 20022cite it
  • K052415Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. · 20052cite it
  • K063746Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 20072cite it
  • K022313Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads, Models RALC30V, RALC45V…Power Medical Interventions, Inc. · 20022cite it

What has FDA decided for it lately?

  • K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical InstrumentPower Medical Interventions, Inc. · 20091 recall
  • K083527Intelligent Articulating Endoscopic Linear Cutter Reverse with ReloadsPower Medical Interventions, Inc. · 20081 recall
  • K081826Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads, Models I30V, I45V…Power Medical Interventions, Inc. · 20081 recall
  • K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 20071 recall
  • K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007
  • K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 20071 recall
  • K063746Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 2007
  • K063075Natural Orifice Linear Cutter Digital Loading UnitsPower Medical Interventions, Inc. · 2006

All 22 as Power Medical Interventions, Inc. →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K021701Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle…Sep 23, 2009
  • K021249FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product…Sep 23, 2009
  • K040024Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular…Sep 23, 2009
  • K071708Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green…Sep 23, 2009
  • K032701Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm…Sep 23, 2009
  • K020343Remote Control Unit with Wire, product code RCW100.Sep 23, 2009

Other applicant names beginning “Power”

FDA records each applicant name separately; these may or may not be the same firm.

Power Products, Inc.-Splintek 3Power Plus Mobility 1Power Analytics Corp. 1Power Medical Devices, LLC 1