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FDA 510(k)

MariGen Wound Extra

K-Number: K190528 · 2019-07-10

ApplicantKerecis Limited
Decision Date2019-07-10
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MariGen Wound Extra is a medical device manufactured by Kerecis Limited. It received FDA 510(k) clearance on 2019-07-10 under approval number K190528. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MariGen Wound Extra?

MariGen Wound Extra is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Kerecis Limited. The 510(k) number is K190528.

When was MariGen Wound Extra approved by the FDA?

MariGen Wound Extra received FDA 510(k) clearance on 2019-07-10, under approval number K190528.

What company makes MariGen Wound Extra?

MariGen Wound Extra is manufactured by Kerecis Limited.

What is the FDA product code for MariGen Wound Extra?

The FDA product code for MariGen Wound Extra is KGN.

Other Devices by Kerecis Limited

K153364Kerecis SecureMesh K192612Kerecis Gingiva Graft K202430Kerecis Reconstruct K213231Kerecis Silicone K241080Kerecis Parvus (50207) K251845Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus

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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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