Starion Instruments Thermal Litigating Shears

• • Terminated Z-1698-2019 FDA Class II ·initiated 22 Mar 2019

  The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.

• • Terminated Z-2239-2010 FDA Unclassified (pre-2012) ·initiated 9 Mar 2010

  The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on".

• • Terminated Z-1972-2010 FDA Unclassified (pre-2012) ·initiated 26 Jun 2008

  Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.

510(k) Number

K062257 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Starion Instruments Power Point Cautery Grasper/Dissector

  Class II

  FDA 510(k) K002547 Active Cleared 20 Oct 2000

• Cautery Grasper/Dissector

  Class II

  FDA 510(k) K994019 Active Cleared 20 Jan 2000

• Thermal Cautery Probe

  Class II

  FDA 510(k) K050308 Active Cleared 25 Feb 2005

• Starion Instruments Power Point Cautery Clamp

  Class II

  FDA 510(k) K001273 Active Cleared 14 Jun 2000

• Cautery Forceps with Footswitch

  Class II

  FDA 510(k) K000250 Active Cleared 7 Mar 2000

• Starion Universal Power Supply

  Class II

  FDA 510(k) K070871 Active Cleared 13 Apr 2007

See all devices from Starion Instruments →