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510(k) K033523

COLLAGEN-ORC ANTIMICROBIAL MATRIX by Johnson & Johnson Medical, Ltd. — Product Code FRO

K033523 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Ltd. for the device "COLLAGEN-ORC ANTIMICROBIAL MATRIX". The FDA issued a decision of Substantially Equivalent on October 21, 2004. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Johnson & Johnson Medical, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2004
Date Received
November 7, 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 Johnson & Johnson Medical, Ltd.

  • K022483 — ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING (February 3, 2003)
  • K014129 — PROMOGRAN MATRIX WOUND DRESSING (February 14, 2002)
  • K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (July 31, 2000)
  • K982641 — ADVANCED NIBP MODULE (March 29, 1999)
  • K983362 — NU-GEL * WOUND DRESSING (December 16, 1998)
  • K982597 — FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (August 20, 1998)
  • K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF (May 18, 1998)
  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
  • K972498 — OBSERVER * CENTRAL STATION (February 17, 1998)
  • K973699 — ULTRALON POWDER FREE LATEX SURGICAL GLOVE (December 16, 1997)

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