Home / 510(k) Clearances / K000054

510(k) K000054

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN by Adri — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2000
Date Received
January 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Adri

  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K011618 — CALGITROL AG SILVER ALGINATE WOUND DRESSING (November 15, 2002)
  • K963656 — FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING (November 12, 1996)
  • K940404 — ALGINATE FIBER TOPICAL WOUND DRESSING (May 4, 1994)
  • K870383 — ALGINATE WOOL FIBER (April 30, 1987)

Other clearances for product code KGN

  • K260218 — LacertaMatrix (February 19, 2026)
  • K253140 — CollOvine™ Wound Powder (February 10, 2026)
  • K251323 — Device 104 Particulate (January 22, 2026)
  • K252673 — LacertaMatrix (December 22, 2025)
  • K253339 — Theracor (December 22, 2025)
  • K250864 — MatriDerm pluS+ Bi-Layer (December 19, 2025)
  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250397 — Helios Dermal Scaffold (August 15, 2025)
  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)