Cleared Traditional

BETA GLUCAN GEL (MACROPRO GEL) (K002078) - FDA 510(k) Clearance

K002078 · Brennen Medical, Inc. · General & Plastic Surgery device
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Oct 2000
Decision
84d
Days
-
Risk

K002078 is an FDA 510(k) clearance for the BETA GLUCAN GEL (MACROPRO GEL). Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Brennen Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 2, 2000 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brennen Medical, Inc. devices

Submission Details

510(k) Number K002078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2000
Decision Date October 02, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 144
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K002078.
TENDERWET ACTIVE
K040517 · Medline Industries, Inc. · Mar 2004
MEDLINE TENDER WET WOUND DRESSING
K991755 · Medline Industries, Inc. · Apr 2000
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994