Cleared Traditional

K950032 - MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING

K950032 · Brennen Medical, Inc. · General & Plastic Surgery device
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Jun 1995
Decision
175d
Days
-
Risk

K950032 is an FDA 510(k) clearance for the MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Brennen Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 28, 1995 after a review of 175 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 Brennen Medical, Inc. devices

FDA 510(k) Submission Details - K950032

510(k) Number K950032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1995
Decision Date June 28, 1995
Days to Decision 175 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
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 171
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K950032.
KENDALL HYDROPHILIC POWDER WOUND DRESSING
K970266 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1997
REPLIDERM WOUND DRESSING
K963228 · Orphan Medical, Inc. · Dec 1996
HYCURE
K955506 · The Hymed Group Corp. · Jan 1996
MESH MATRIX WOUND DRESSING
K950281 · Brennen Medical, Inc. · Apr 1995
E-Z DERM BIOSYNTHETIC WOUND DRESSING
K935189 · Brennen Medical, Inc. · Jul 1994