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510(k) K050086

BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING by Brennen Medical, Inc. — Product Code FRO

K050086 is an FDA 510(k) premarket notification submitted by Brennen Medical, Inc. for the device "BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 17, 2006. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Brennen Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2006
Date Received
January 13, 2005
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 Brennen Medical, Inc.

  • K113866 — PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX (March 23, 2012)
  • K111436 — PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX (October 14, 2011)
  • K081272 — PORCINE SURGICAL MESH; DERMAL MATRIX (July 31, 2008)
  • K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (March 7, 2003)
  • K021835 — BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX (October 17, 2002)
  • K002078 — BETA GLUCAN GEL (MACROPRO GEL) (October 2, 2000)
  • K002077 — GLUCANPRO CREAM (October 2, 2000)
  • K000519 — GLUCANPRO (May 1, 2000)
  • K000518 — MACROPRO GEL (May 1, 2000)
  • K982825 — BRENNEN MEDICAL BETA GLUCAN GEL (November 6, 1998)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • 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)

FDA data resources