#500 Series Forceps W/Cut/Coagulate Switches

• • Terminated Z-1994-2012 FDA Class II ·initiated 1 Jun 2012

  Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.

• 3 recalls, same reason

  • Terminated Z-1997-2012 FDA Class II ·initiated 1 Jun 2012
  • Terminated Z-1999-2012 FDA Class II ·initiated 1 Jun 2012
  • Terminated Z-1998-2012 FDA Class II ·initiated 1 Jun 2012

  Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label.

510(k) Number

K885199 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• #820/821 Bipolar Forceps

  Class II

  FDA 510(k) K884175 Active Cleared 24 Oct 1988

• 600 & 900 Series Electrodes & 755 & 756 Handle

  Class II

  FDA 510(k) K885200 Active Cleared 13 Jan 1989

• Insulated Speculum W/ Smoke Evacuator Option

  Class II

  FDA 510(k) K922154 Active Cleared 21 Apr 1994

• Olsen Laparoscopic Instr, Disposable, Single Use

  Class II

  FDA 510(k) K912611 Active Cleared 15 Apr 1992

• Teflon Coated Electrodes/Electrodes Handles

  Class II

  FDA 510(k) K913108 Active Cleared 23 Dec 1991

• Smoke/Odor Evacuator #757

  Class II

  FDA 510(k) K912612 Active Cleared 1 Nov 1991

See all devices from Olsen Electrosurgical, Inc. →