PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K210135 ↗

FDA Product Code

FRO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac

  Class II

  FDA 510(k) K212320 Active Cleared 28 Sep 2021

• 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit

  Class II

  FDA 510(k) K221585 Active Cleared 23 Mar 2023

• Prevena Restor Adapti-Form Dressing

  Class II

  FDA 510(k) K220660 Active Cleared 1 Jul 2022

• 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)

  Class II

  FDA 510(k) K211521 Active Cleared 20 Dec 2021