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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 the device name listed in this FDA 510(k) record. The listed applicant is Organogenesis, Inc.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) 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. The listed applicant is Organogenesis, Inc.. The 510(k) number is K220317.

When did PuraPly Micronized Wound Matrix (PuraPly MZ) receive FDA 510(k) clearance?

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

Who is the listed applicant for PuraPly Micronized Wound Matrix (PuraPly MZ)?

The FDA 510(k) record lists Organogenesis, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Organogenesis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212579FortiShield (Biosynthetic Wound Matrix)

Related Devices (Code: KGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

Official Source

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

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