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

Submission Details

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.

Device Classification

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

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 K182010.
scaffolene CL100 Bioresorbable Collagen Matrix
K192346 · Freudenberg Technology Innovation SE & Co. KG · Feb 2020
Cytal Wound Matrix 3-Layer
K192725 · Acell, Inc. · Oct 2019
MariGen Wound Extra
K190528 · Kerecis Limited · Jul 2019
Geistlich Derma-Gide
K182838 · Geistlich Pharma AG · Nov 2018
NeoMatriX Wound Matrix
K181330 · Nextgen Biologics, Inc. · Oct 2018
SURECELL Gelling Fiber Wound Dressing
K173005 · Jiangsu Newvalue Medical Producst Co.,Ltd · May 2018