Conmed Select One Laparoscopy Electrode

• 2 recalls, same reason

  • Terminated Z-1412-04 FDA Unclassified (pre-2012) ·initiated 9 Aug 2004
  • Terminated Z-1413-04 FDA Unclassified (pre-2012) ·initiated 9 Aug 2004

  Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.

• • Terminated Z-1301-04 FDA Unclassified (pre-2012) ·initiated 28 Jun 2004

  Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock.

510(k) Number

K960808 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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