Cleared Traditional

K250864 - MatriDerm pluS+ Bi-Layer

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

FDA 510(k) Submission Details - K250864

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
158d slower than avg
Panel avg: 115d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

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.

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

All 95
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