Fortex(Tm) Wound Dressing

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K914314 ↗

FDA Product Code

KMF

Device Class

Class I

Regulation

21 CFR Part 880.5090

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Bill Evans-Klenz

  Class I

  FDA 510(k) K944033 Active Cleared 7 Oct 1994

• Epi-Lock Wound Dressing

  Unclassified

  FDA 510(k) K926034 Active Cleared 20 Apr 1993

• Mon-Klenz

  Class I

  FDA 510(k) K941163 Active Cleared 18 May 1994

• Amerse

  Class I

  FDA 510(k) K931477 Active Cleared 17 Jun 1994

• Kaltostat Wound Dressing

  Unclassified

  FDA 510(k) K910059 Active Cleared 20 Mar 1991

• Vesta-Syde(R) Interim Instr Decontamination System

  Class I

  FDA 510(k) K931816 Active Cleared 26 May 1994

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