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510(k) K011618

CALGITROL AG SILVER ALGINATE WOUND DRESSING by Adri — Product Code FRO

K011618 is an FDA 510(k) premarket notification submitted by Adri for the device "CALGITROL AG SILVER ALGINATE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on November 15, 2002. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Adri has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2002
Date Received
May 25, 2001
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 Adri

  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K000054 — FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN (March 13, 2000)
  • 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 FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • 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)

FDA data resources