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510(k) K033453

KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING by Tyco Healthcare — Product Code FRO

K033453 is an FDA 510(k) premarket notification submitted by Tyco Healthcare for the device "KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING". The FDA issued a decision of Substantially Equivalent on April 29, 2004. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Tyco Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2004
Date Received
October 30, 2003
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 Tyco Healthcare

  • K071049 — DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR (October 16, 2007)
  • K070685 — KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 (September 14, 2007)
  • K070653 — KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 (September 12, 2007)
  • K061492 — MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE (August 3, 2006)
  • K042709 — DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER (January 18, 2005)
  • K040897 — DOVER ROB-NEL CATHETER (July 20, 2004)
  • K040649 — KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE (July 15, 2004)
  • K041243 — DOVER RED RUBBER ROBINSON CATHETER (July 7, 2004)
  • K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PRE (June 30, 2004)
  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)

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