Home / 510(k) Clearances / K210135

510(k) K210135

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing by 3M Healthcare Business Group — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2022
Date Received
January 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by 3M Healthcare Business Group

  • K221585 — 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complet (March 23, 2023)
  • K220660 — Prevena Restor Adapti-Form Dressing (July 1, 2022)
  • K211521 — 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, (December 20, 2021)
  • K212320 — Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technolog (September 28, 2021)

Other clearances for product code FRO

  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)
  • K250890 — SBC1 Cream (January 12, 2026)
  • K252759 — revyve® Antimicrobial Skin and Wound Cleanser (January 8, 2026)
  • K251757 — Puracyn® Plus Antimicrobial Irrigation Solution (January 5, 2026)
  • K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber (December 19, 2025)
  • K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (November 19, 2025)
  • K250115 — Hemastyl(™) Wound Dressing (October 14, 2025)