Cleared Traditional

InnovaMatrix (K193552) - FDA 510(k) Clearance

K193552 · Triad Life Sciences, Inc. · General & Plastic Surgery device
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Oct 2020
Decision
306d
Days
-
Risk

K193552 is an FDA 510(k) clearance for the InnovaMatrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Triad Life Sciences, Inc. (Memphis, US). The FDA issued a Cleared decision on October 21, 2020 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Triad Life Sciences, Inc. devices

Submission Details

510(k) Number K193552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date October 21, 2020
Days to Decision 306 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
191d slower than avg
Panel avg: 115d · This submission: 306d
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 73
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