Cleared Traditional

REPLIDERM WOUND DRESSING (K963228) - FDA 510(k) Clearance

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

Submission Details

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
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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