Cleared Traditional

NeoMatriX Wound Matrix (K210024) - FDA 510(k) Clearance

K210024 · Nextgen Biologics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
276d
Days
-
Risk

K210024 is an FDA 510(k) clearance for the NeoMatriX Wound Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Nextgen Biologics, Inc. (Alachua, US). The FDA issued a Cleared decision on October 7, 2021 after a review of 276 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 Nextgen Biologics, Inc. devices

Submission Details

510(k) Number K210024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2021
Decision Date October 07, 2021
Days to Decision 276 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
161d slower than avg
Panel avg: 115d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

Hogan Lovells Llp
Janice Hogan

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 73
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