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510(k) K100029

MEPILEX BORDER AG DRESSING by Molnlycke Health Care — Product Code FRO

K100029 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care for the device "MEPILEX BORDER AG DRESSING". The FDA issued a decision of Substantially Equivalent on September 15, 2010. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Molnlycke Health Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2010
Date Received
January 6, 2010
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 Molnlycke Health Care

  • K130852 — AVANCE® FOAM ABDOMINAL DRESSING KIT (April 14, 2014)
  • K130040 — MEPITEL AG (February 12, 2014)
  • K123892 — MEPILEX TRANSFER AG (April 5, 2013)
  • K122132 — AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LA (January 17, 2013)
  • K102923 — BARRIER N95 PARTICULATE RESPIRATOR (November 19, 2010)
  • K061554 — MEPILEX AG ABSORBENT SILICONE-COATED DRESSING (January 25, 2007)
  • K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPREN (October 5, 2006)
  • K051625 — BARRIER SURGICAL DRAPES (July 14, 2005)
  • K050786 — BARRIER SURGICAL GOWNS (May 9, 2005)
  • K031131 — KLINIDRAPE SURGICAL DRAPES (June 10, 2003)

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