Disposable Re-New Forceps

• • Terminated Z-1740-2018 FDA Class II ·initiated 1 Nov 2017

  Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

• 2 recalls, same reason

  • Terminated Z-1986-2014 FDA Class II ·initiated 12 May 2014
  • Terminated Z-1987-2014 FDA Class II ·initiated 12 May 2014

  Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw

• • Terminated Z-1635-2014 FDA Class II ·initiated 14 Apr 2014

  Grasper jaw may break when force is applied to the jaw

• 2 recalls, same reason

  • Terminated Z-3086-2011 FDA Unclassified (pre-2012) ·initiated 18 Jul 2011
  • Terminated Z-3085-2011 FDA Unclassified (pre-2012) ·initiated 18 Jul 2011

  Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled as 3262 (Long Fenestrated Grasper

510(k) Number

K981389 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Accushear Laparoscopic Surgical Instruments

  Class II

  FDA 510(k) K982984 Active Cleared 21 Oct 1998

• Bradbury Intraocular Retinal Kit Cat #200

  Class I

  FDA 510(k) K881049 Active Cleared 12 Sep 1988

• Re-New Laparoscopic Instruments

  Class II

  FDA 510(k) K962119 Active Cleared 9 Aug 1996

• Microline Inc. Reusable Laparoscopic Clip Applier with Implantable Titanium Clips, Model M/L-10

  Class II

  FDA 510(k) K013695 Active Cleared 8 Jan 2002

• Microline Cat #100

  Class II

  FDA 510(k) K880943 Active Cleared 26 May 1988

• Quick Switch Laparoscopic Instruments

  Class II

  FDA 510(k) K932648 Active Cleared 12 Oct 1993

See all devices from Microline Pentax, Inc. →