Single Use Active Electrode Handle

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780978 ↗

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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  Class I

  FDA 510(k) K802774 Active Cleared 16 Dec 1980

• Fiber Optic Light Guide CAT#60-0768

  Class I

  FDA 510(k) K802767 Active Cleared 16 Dec 1980

• Fiber Optic Headlight #60-0766766

  Class II

  FDA 510(k) K802770 Active Cleared 11 Dec 1980

• Fiber Optic ADAPTERS#60-0893

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  FDA 510(k) K810300 Active Cleared 27 Feb 1981

• A.T.S. 1500 Tourniquet

  Class I

  FDA 510(k) K870784 Active Cleared 18 Mar 1987

• Single Use Ball Electrode

  Class II

  FDA 510(k) K780976 Active Cleared 22 Jun 1978

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