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FDA 510(k)

PuraPly Micronized Wound Matrix (PuraPly MZ)

K-Number: K220317 · 2022-07-01

ApplicantOrganogenesis, Inc.
Decision Date2022-07-01
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

PuraPly Micronized Wound Matrix (PuraPly MZ) is a medical device manufactured by Organogenesis, Inc.. It received FDA 510(k) clearance on 2022-07-01 under approval number K220317. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PuraPly Micronized Wound Matrix (PuraPly MZ)?

PuraPly Micronized Wound Matrix (PuraPly MZ) is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Organogenesis, Inc.. The 510(k) number is K220317.

When was PuraPly Micronized Wound Matrix (PuraPly MZ) approved by the FDA?

PuraPly Micronized Wound Matrix (PuraPly MZ) received FDA 510(k) clearance on 2022-07-01, under approval number K220317.

What company makes PuraPly Micronized Wound Matrix (PuraPly MZ)?

PuraPly Micronized Wound Matrix (PuraPly MZ) is manufactured by Organogenesis, Inc..

What is the FDA product code for PuraPly Micronized Wound Matrix (PuraPly MZ)?

The FDA product code for PuraPly Micronized Wound Matrix (PuraPly MZ) is KGN.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT06073808 The Role of Amnion Membrane Allografts in Nipple Preservation NOT_YET_RECRUITING NCT06919809 Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery COMPLETED NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT06857708 The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® RECRUITING

Other Devices by Organogenesis, Inc.

K212579FortiShield (Biosynthetic Wound Matrix)

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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