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510(k) K131176

ROSS RU SKIN DISCONTINUITIES by Biotd S.A. — Product Code FRO

K131176 is an FDA 510(k) premarket notification submitted by Biotd S.A. for the device "ROSS RU SKIN DISCONTINUITIES". The FDA issued a decision of Substantially Equivalent on May 12, 2014. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Biotd S.A. has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2014
Date Received
Apr 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

Other clearances by Biotd S.A.

  • K162017 — Ross Ru Wound Dressing Gel (Apr 20, 2017)
  • K141637 — SPB SKIN EMULSION (Jun 3, 2015)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (Sep 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (Aug 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (Aug 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (Jun 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (Jun 24, 2026)
  • K261638 — Bonvadis® (Jun 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (Apr 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (Mar 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (Mar 13, 2026)

FDA data resources