Cleared Traditional

K201577 - MatriDerm

K201577 · Medskin Solutions Dr. Suwelack AG · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2021
Decision
210d
Days
-
Risk

K201577 is an FDA 510(k) clearance for the MatriDerm. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Medskin Solutions Dr. Suwelack AG (Billerbeck, DE). The FDA issued a Cleared decision on January 7, 2021 after a review of 210 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 Medskin Solutions Dr. Suwelack AG devices

FDA 510(k) Submission Details - K201577

510(k) Number K201577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2020
Decision Date January 07, 2021
Days to Decision 210 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 115d · This submission: 210d
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)

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