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510(k) K153723

ACTICOAT Surgical Dressing by Smith & Nephew Medical Limited — Product Code FRO

K153723 is an FDA 510(k) premarket notification submitted by Smith & Nephew Medical Limited for the device "ACTICOAT Surgical Dressing". The FDA issued a decision of Substantially Equivalent on September 14, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Smith & Nephew Medical Limited has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2016
Date Received
December 28, 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 Smith & Nephew Medical Limited

  • K242146 — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (December 17, 2024)
  • K223526 — ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular F (August 18, 2023)
  • K220964 — VERSAJET Hydrosurgery System (III) (May 16, 2023)
  • K213853 — RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing (February 10, 2023)
  • K223041 — Renasys Edge (66803126) (November 22, 2022)
  • K202783 — Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dress (January 14, 2022)
  • K203716 — PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negati (December 14, 2021)
  • K202157 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Neg (October 30, 2020)
  • K191760 — PICO 14 Single Use Negative Pressure Wound Therapy System (December 5, 2019)
  • K181822 — RENASYS Touch; RENASYS Y-Connector (March 21, 2019)

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