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510(k) K113836

BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) by Avery Dennison Belgie Bvba — Product Code FRO

K113836 is an FDA 510(k) premarket notification submitted by Avery Dennison Belgie Bvba for the device "BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)". The FDA issued a decision of Substantially Equivalent on September 24, 2012. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Avery Dennison Belgie Bvba has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2012
Date Received
December 28, 2011
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 Avery Dennison Belgie Bvba

  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K170407 — BD ChloraShield IV Dressing with CHG Antimicrobial (July 17, 2017)
  • K152923 — BD ChloraShield IV Dressing with CHG Antimicrobial (November 5, 2015)
  • K133764 — CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL (March 13, 2014)

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