Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument

• • Terminated Z-0409-2010 FDA Unclassified (pre-2012) ·initiated 23 Sep 2009

  Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.

510(k) Number

K091215 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Idrives, Idrivec, Idrivef with Vascular Indications

  Class II

  FDA 510(k) K073148 Active Cleared 7 Dec 2007

• Power Circular Stapler Digital Loading Unit with and Without Sheath

  Class II

  FDA 510(k) K061649 Active Cleared 1 Sep 2006

• Surgassist Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units with Reloads

  Class II

  FDA 510(k) K030653 Active Cleared 31 Mar 2003

• Surgassist Straight Linear 4 Row No Knife Dlus with Reloads

  Class II

  FDA 510(k) K040398 Active Cleared 24 Mar 2004

• Surgassist System Straight Linear Cutter Digital Loading Unit, 55mm, 30mm with Blue and Green Reload Cartridges

  Class II

  FDA 510(k) K020719 Active Cleared 10 May 2002

• Surgassist Circular Stapler Digital Loading Units - 29 Mm, Model CS29

  Class II

  FDA 510(k) K040024 Active Cleared 4 Feb 2004

See all devices from Power Medical Interventions, Inc. →

• What is the Intelligent Power Unit, Console, Delivery System, and Surgical Instrument system used for?

  The system is intended for use in general and plastic surgery procedures as a staple, implantable device, designed to perform stapling and implantation functions during these surgical interventions.

• How is the Intelligent Power Unit, Console, Delivery System, and Surgical Instrument system supplied?

  The device is supplied by Power Medical Interventions, Inc. as a complete system comprising an intelligent power unit, intelligent console, intelligent delivery system, and intelligent surgical instrument, all components working together as a single surgical instrument system.

• Is the Intelligent Power Unit, Console, Delivery System, and Surgical Instrument system sterile and for single use?

  The device data does not specify sterility or single-use status; therefore, no conclusion can be drawn about whether the system is sterile, single-use, or reusable based on the provided information.

• What regulatory pathway was used for the Intelligent Power Unit, Console, Delivery System, and Surgical Instrument system?

  The device received FDA 510(k) clearance under K091215, with a decision date of May 18, 2009, and is classified as a Class II medical device under FDA regulation number 878.4750.