Cleared Traditional

K964240 - BIAFINE WOUND DRESSING EMULSION

K964240 · Medix Pharmaceuticals Americas, Inc. · General & Plastic Surgery device
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Jan 1997
Decision
90d
Days
-
Risk

K964240 is an FDA 510(k) clearance for the BIAFINE WOUND DRESSING EMULSION. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Medix Pharmaceuticals Americas, Inc. (Washington, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medix Pharmaceuticals Americas, Inc. devices

FDA 510(k) Submission Details - K964240

510(k) Number K964240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1996
Decision Date January 22, 1997
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 87
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K964240.
IAMIN IMPREGNATED GAUZE DRESSING
K965005 · Procyte Corp. · Feb 1997
BIONECT CREAM
K963004 · Fidia Pharmaceutical Corp. · Feb 1997
IAMIN WET DRESSING (COPPER-SALINE)
K964468 · Procyte Corp. · Feb 1997
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · Sage Pharmaceuticals, Inc. · Jan 1997
MULTIDEX HYDROPHILIC WOUND DRESSING GEL
K962917 · Lange Medical Products, Inc. · Dec 1996
BRENNEN MEDICAL GLUCAN II WOUND DRESSING
K964241 · Brennen Medical, Inc. · Dec 1996