Cleared Traditional

K963228 - REPLIDERM WOUND DRESSING

K963228 · Orphan Medical, Inc. · General & Plastic Surgery device
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Dec 1996
Decision
121d
Days
-
Risk

K963228 is an FDA 510(k) clearance for the REPLIDERM WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Orphan Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on December 18, 1996 after a review of 121 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 Orphan Medical, Inc. devices

FDA 510(k) Submission Details - K963228

510(k) Number K963228 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 19, 1996
Decision Date December 18, 1996
Days to Decision 121 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
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 124
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K963228.
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
K982597 · Johnson & Johnson Medical, Inc. · Aug 1998
SIS WOUND DRESSING
K973170 · Cook Biotech, Inc. · Apr 1998
KENDALL HYDROPHILIC POWDER WOUND DRESSING
K970266 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1997
HYCURE
K955506 · The Hymed Group Corp. · Jan 1996
MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING
K950032 · Brennen Medical, Inc. · Jun 1995
MESH MATRIX WOUND DRESSING
K950281 · Brennen Medical, Inc. · Apr 1995