Cleared Traditional

K213607 - Geistlich Wound Matrix PLUS

K213607 · Geistlich Pharma AG · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2022
Decision
164d
Days
-
Risk

K213607 is an FDA 510(k) clearance for the Geistlich Wound Matrix PLUS. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Geistlich Pharma AG (Wolhusen, Lu, CH). The FDA issued a Cleared decision on April 28, 2022 after a review of 164 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 Geistlich Pharma AG devices

Submission Details

510(k) Number K213607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2021
Decision Date April 28, 2022
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

Streamline Regulatory
Stephen P Rhodes

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 84
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K213607.
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Cellusheet, Cellufil
K213092 · Human Biosciences, Inc. · Dec 2021
INTEGRA Wound Matrix (Macro-Channels)
K210128 · Integra LifeSciences Corporation · Oct 2021