FDA 510(k)

PuraPly微米化伤口基质（PuraPly MZ）

K号: K220317 · 2022-07-01

决定日期2022-07-01

产品代码KGN

决定实质等同

器械摘要

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.

常见问题

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.

列明Organogenesis, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K212579FortiShield (生物合成伤口基质)

相关器械（代码：KGN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 手术基质，1cc（CG-01AP）；Accelagen Plus 手术基质，3cc（CG-03AP）；Accelagen Plus 手术基质，5cc（CG-05AP）；Accelagen Plus 手术条带，125x25x2mm（CG-125X25AP）；Accelagen Plus 手术条带，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596胶原蛋白伤口粉Ventris Medical K260669Endoform 皮肤模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

官方来源

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