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510(k) K061467

EXSEPT WC WOUND CLEANSER by Alcavis International, Inc. — Product Code FRO

K061467 is an FDA 510(k) premarket notification submitted by Alcavis International, Inc. for the device "EXSEPT WC WOUND CLEANSER". The FDA issued a decision of Substantially Equivalent on February 15, 2007. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Alcavis International, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2007
Date Received
May 26, 2006
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 Alcavis International, Inc.

  • K082858 — EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER (May 27, 2009)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • 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)

FDA data resources