Cleared Traditional

K963004 - BIONECT CREAM

K963004 · Fidia Pharmaceutical Corp. · General & Plastic Surgery device
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Feb 1997
Decision
194d
Days
-
Risk

K963004 is an FDA 510(k) clearance for the BIONECT CREAM. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Fidia Pharmaceutical Corp. (Washington, US). The FDA issued a Cleared decision on February 12, 1997 after a review of 194 days - an extended review 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: 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 Fidia Pharmaceutical Corp. devices

FDA 510(k) Submission Details - K963004

510(k) Number K963004 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 02, 1996
Decision Date February 12, 1997
Days to Decision 194 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 115d · This submission: 194d
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 66
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K963004.
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · B.Braun Medical, Inc. · Apr 1997
ACRYDERM GEL WOUND DRESSING
K970693 · Acrymed, Inc. · Mar 1997
IAMIN IMPREGNATED GAUZE DRESSING
K965005 · Procyte Corp. · Feb 1997
IAMIN WET DRESSING (COPPER-SALINE)
K964468 · Procyte Corp. · Feb 1997
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · Sage Pharmaceuticals, Inc. · Jan 1997
BRENNEN MEDICAL GLUCAN II WOUND DRESSING
K964241 · Brennen Medical, Inc. · Dec 1996