Cleared Traditional

K250864 - MatriDerm pluS+ Bi-Layer (FDA 510(k) Clearance)

K250864 · Medskin Solutions Dr. Suwelack AG · General & Plastic Surgery device
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Dec 2025
Decision
273d
Days
-
Risk

K250864 is an FDA 510(k) clearance for the MatriDerm pluS+ Bi-Layer. 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 December 19, 2025 after a review of 273 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

Submission Details

510(k) Number K250864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2025
Decision Date December 19, 2025
Days to Decision 273 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
159d slower than avg
Panel avg: 114d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

Secure BioMed Evaluations
Justin Gracyalny

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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