Conmed System 5000 Esu

• • Terminated Z-1508-06 FDA Unclassified (pre-2012) ·initiated 5 Sep 2006

  Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.

510(k) Number

K020186 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• ECG Electrode (Various)

  Class II

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  Class II

  FDA 510(k) K972628 Active Cleared 27 Aug 1997

• Conmed Universal Plus

  Class II

  FDA 510(k) K934828 Active Cleared 7 Mar 1994

• Electrosurgical Dispersive Electrode

  Class II

  FDA 510(k) K983782 Active Cleared 25 Jan 1999

• Bend-A-Beam Hand Control Malleable ABC Handpiece

  Class II

  FDA 510(k) K961505 Active Cleared 18 Jul 1996

• Exactrace Adult Foam Monitoring ECG Electrode Conmed Model 1510 and Instatrace Adult Diaphoretic Foam ECG Electrode Conm

  Class II

  FDA 510(k) K963787 Active Cleared 11 Mar 1997

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