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510(k) K012116

ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING by Acrymed, Inc. — Product Code FRO

K012116 is an FDA 510(k) premarket notification submitted by Acrymed, Inc. for the device "ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on September 12, 2001. 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 12, 2001
Date Received
July 6, 2001
Clearance Type
Special
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)
  • K082459 — ACRYDERM ABSORBENT OXYGEN DRESSING (September 19, 2008)
  • 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)
  • 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

  • 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