Correct-A-Count

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K853374 ↗

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Surgi-Tek Tube Positioner

  Not classified

  FDA 510(k) K863279 Active Cleared 9 Sep 1986

• Infant Electrosurgical Dispersive Electrode

  Class II

  FDA 510(k) K882421 Active Cleared 30 Jun 1988

• Pro-Clean

  Not classified

  FDA 510(k) K862367 Active Cleared 8 Jul 1986

• Elan-E Disposalbe Drape

  Class II

  FDA 510(k) K882494 Active Cleared 8 Jul 1988

• Surgi-Wipes

  Not classified

  FDA 510(k) K863278 Active Cleared 2 Sep 1986

• Dermamarker

  Class I

  FDA 510(k) K863280 Active Cleared 9 Sep 1986

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