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510(k) K153674

Sorbact Foam Gentle Border, Sorbact Superabsorbent by Abigo Medical AB — Product Code FRO

K153674 is an FDA 510(k) premarket notification submitted by Abigo Medical AB for the device "Sorbact Foam Gentle Border, Sorbact Superabsorbent". The FDA issued a decision of Substantially Equivalent on July 1, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Abigo Medical AB has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2016
Date Received
December 21, 2015
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 Abigo Medical AB

  • K171225 — Sorbact Wound Dressing-Ribbon Gauze (August 21, 2017)
  • K100591 — SORBACT (January 24, 2011)
  • K063059 — SORBACT WOUND DRESSING (April 19, 2007)
  • K920840 — OTOVENT (October 5, 1992)

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