Cleared Traditional

K964241 - BRENNEN MEDICAL GLUCAN II WOUND DRESSING

K964241 · Brennen Medical, Inc. · General & Plastic Surgery device
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Dec 1996
Decision
49d
Days
-
Risk

K964241 is an FDA 510(k) clearance for the BRENNEN MEDICAL GLUCAN II WOUND DRESSING. 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 December 12, 1996 after a review of 49 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

FDA 510(k) Submission Details - K964241

510(k) Number K964241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1996
Decision Date December 12, 1996
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

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 90
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K964241.
BIAFINE WOUND DRESSING EMULSION
K964240 · Medix Pharmaceuticals Americas, Inc. · Jan 1997
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · Sage Pharmaceuticals, Inc. · Jan 1997
MULTIDEX HYDROPHILIC WOUND DRESSING GEL
K962917 · Lange Medical Products, Inc. · Dec 1996
DERMAMEND GEL
K962089 · Dermarx Corp. · Nov 1996
CHONDROPROTEC
K961930 · The Hymed Group Corp. · Oct 1996
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
K962218 · Carrington Laboratories, Inc. · Sep 1996