Stryker Interventional Pain Rf Generator

• • Terminated Z-0915-2011 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010

  This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of the molded section of the plug and a build up of heat which can cause charring, electric shock or fire. To this date there have been zero complaint for this

510(k) Number

K032601 ↗

FDA Product Code

GXD

Device Class

Class II

Regulation

21 CFR Part 882.4400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Valley Forge Bipolar Pen or Forceps

  Class II

  FDA 510(k) K910510 Active Cleared 22 Apr 1991

• Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical Instruments

  Class II

  FDA 510(k) K042604 Active Cleared 22 Oct 2004

• Bi-Tech I Bipolar Coagulator/Cutting System

  Class II

  FDA 510(k) K924188 Active Cleared 10 Dec 1992

• Valley Forge Scien-Tens Unit & Access. Lead Wire &

  Class II

  FDA 510(k) K853992 Active Cleared 21 Feb 1986

• Malis Surgical Loupes

  Class I

  FDA 510(k) K874845 Active Cleared 23 Dec 1987

• Malis 2000 Bipolar Electrosurgical System

  Class II

  FDA 510(k) K050364 Active Cleared 9 Mar 2005

See all devices from Valley Forge Scientific Corp. →