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510(k) K082459

ACRYDERM ABSORBENT OXYGEN DRESSING by Acrymed, Inc. — Product Code FRO

K082459 is an FDA 510(k) premarket notification submitted by Acrymed, Inc. for the device "ACRYDERM ABSORBENT OXYGEN DRESSING". The FDA issued a decision of Substantially Equivalent on September 19, 2008. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Acrymed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2008
Date Received
August 26, 2008
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 Acrymed, Inc.

  • K091354 — ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING (October 21, 2009)
  • K083103 — ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B (February 26, 2009)
  • K070333 — ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL (July 10, 2007)
  • K061232 — ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 (October 6, 2006)
  • K011994 — ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 (November 8, 2001)
  • K012116 — ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING (September 12, 2001)
  • K002909 — ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 (October 13, 2000)
  • K002599 — MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, (September 21, 2000)
  • K991818 — ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 10 (April 17, 2000)
  • K992032 — ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 (August 19, 1999)

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