Cleared Traditional

K182010 - ProgenaMatrix

K182010 · Cell Constructs I, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
174d
Days
-
Risk

K182010 is an FDA 510(k) clearance for the ProgenaMatrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Cell Constructs I, LLC (Woodstock, US). The FDA issued a Cleared decision on January 17, 2019 after a review of 174 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 Cell Constructs I, LLC devices

FDA 510(k) Submission Details - K182010

510(k) Number K182010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2018
Decision Date January 17, 2019
Days to Decision 174 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 115d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

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

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

All 151
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