Home / 510(k) Clearances / K121275

510(k) K121275

AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER by Convatec, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2012
Date Received
April 27, 2012
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, Inc.

  • K250699 — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twi (July 1, 2025)
  • K243228 — Flexi-Seal AIR (with ENFit Connector) (March 28, 2025)
  • K232665 — GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air (January 25, 2024)
  • K230400 — Cure Catheter Closed System; Cure Dextra Closed System (November 8, 2023)
  • K221593 — Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus (November 17, 2022)
  • K162906 — Flexi-Seal PROTECT Fecal Management System (March 7, 2017)
  • K150350 — Flexi-Seal Signal Fecal Management System (July 21, 2015)
  • K140953 — GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER (August 1, 2014)
  • K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE (June 6, 2013)
  • K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM (April 26, 2012)

Other clearances for product code FRO

  • 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)
  • K250890 — SBC1 Cream (January 12, 2026)
  • K252759 — revyve® Antimicrobial Skin and Wound Cleanser (January 8, 2026)
  • K251757 — Puracyn® Plus Antimicrobial Irrigation Solution (January 5, 2026)
  • K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber (December 19, 2025)
  • K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (November 19, 2025)
  • K250115 — Hemastyl(™) Wound Dressing (October 14, 2025)