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510(k) K000518

MACROPRO GEL by Brennen Medical, Inc. — Product Code MGQ

K000518 is an FDA 510(k) premarket notification submitted by Brennen Medical, Inc. for the device "MACROPRO GEL". The FDA issued a decision of Substantially Equivalent on May 1, 2000. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), 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
May 1, 2000
Date Received
February 16, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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)
  • K050086 — BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING (February 17, 2006)
  • K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (March 7, 2003)
  • K021835 — BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX (October 17, 2002)
  • K002077 — GLUCANPRO CREAM (October 2, 2000)
  • K002078 — BETA GLUCAN GEL (MACROPRO GEL) (October 2, 2000)
  • K000519 — GLUCANPRO (May 1, 2000)
  • K982825 — BRENNEN MEDICAL BETA GLUCAN GEL (November 6, 1998)

Other clearances for product code MGQ

  • K171879 — HylaGuard Moisturizing Cream (October 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (July 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)
  • K040517 — TENDERWET ACTIVE (March 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (August 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)

FDA data resources