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FDA 510(k)

ProgenaMatrix

K-Number: K182010 · 2019-01-17

ApplicantCell Constructs I, LLC
Decision Date2019-01-17
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

ProgenaMatrix is a medical device manufactured by Cell Constructs I, LLC. It received FDA 510(k) clearance on 2019-01-17 under approval number K182010. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProgenaMatrix?

ProgenaMatrix is a medical device that received FDA 510(k) clearance on 2019-01-17. It is manufactured by Cell Constructs I, LLC. The 510(k) number is K182010.

When was ProgenaMatrix approved by the FDA?

ProgenaMatrix received FDA 510(k) clearance on 2019-01-17, under approval number K182010.

What company makes ProgenaMatrix?

ProgenaMatrix is manufactured by Cell Constructs I, LLC.

What is the FDA product code for ProgenaMatrix?

The FDA product code for ProgenaMatrix is KGN.

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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