Re-New Laparoscopic Instruments

• • Terminated Z-1741-2018 FDA Class II ·initiated 1 Nov 2017

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

• • Terminated Z-0507-2018 FDA Class II ·initiated 13 Jul 2017

  The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.

510(k) Number

K962119 ↗

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

• 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

• Disposable Re-New Forceps

  Class II

  FDA 510(k) K981389 Active Cleared 29 May 1998

• 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. →