Cleared Special

K210580 - InnovaMatrix FS (FDA 510(k) Clearance)

K210580 · Triad Life Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
54d
Days
-
Risk

K210580 is an FDA 510(k) clearance for the InnovaMatrix FS. 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 April 21, 2021 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Triad Life Sciences, Inc. devices

Submission Details

510(k) Number K210580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2021
Decision Date April 21, 2021
Days to Decision 54 days
Submission Type Special
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
60d faster than avg
Panel avg: 114d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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.

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