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510(k) K080383

AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING by Convatec, A Division of E.R. Squibb & Sons, LLC — Product Code FRO

K080383 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons, LLC for the device "AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING". The FDA issued a decision of Substantially Equivalent on May 2, 2008. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Convatec, A Division of E.R. Squibb & Sons, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
February 12, 2008
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 Convatec, A Division of E.R. Squibb & Sons, LLC

  • K090254 — SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) (September 4, 2009)
  • K063271 — AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED AN (April 16, 2007)
  • K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING (June 21, 2002)
  • K990964 — SIGNADRESS DUODERM DRESSING (May 18, 1999)
  • K984388 — HA ABSORBENT WOUND DRESSING (March 3, 1999)
  • K980720 — NONWOVEN PAD (April 15, 1998)
  • K980382 — NON-WOVEN COMPRESS (March 9, 1998)
  • K974823 — NONWOVEN DRESSING (February 20, 1998)
  • K974205 — KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON (February 6, 1998)
  • K974304 — GERMICIDAL CLOTH (January 13, 1998)

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