FDA 510(k)

SurgiAid® Collagen Wound Dressing

K号: K223126 · 2023-10-11

决定日期2023-10-11

产品代码KGN

决定实质等同

器械摘要

SurgiAid® Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Maxigen Biotech, Inc.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K223126. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the SurgiAid® Collagen Wound Dressing?

SurgiAid® Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Maxigen Biotech, Inc.. The 510(k) number is K223126.

When did SurgiAid® Collagen Wound Dressing receive FDA 510(k) clearance?

SurgiAid® Collagen Wound Dressing received FDA 510(k) clearance on 2023-10-11, under 510(k) number K223126.

Who is the listed applicant for SurgiAid® Collagen Wound Dressing?

FDA 510(k)记录中列出Maxigen Biotech, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for SurgiAid® Collagen Wound Dressing?

The FDA product code for SurgiAid® Collagen Wound Dressing is KGN.

列明Maxigen Biotech, 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。

K253989HARU Orgasm 杰克·赫尔水基润滑剂（WL-OJ）；HARU Orgasm 水基润滑剂（WL-OR）；HARU STEAMY 水基润滑剂（WL-ST）K242100SurgiAid Collagen Wound Dressing (HA)K230529HealiAid 牙科胶原蛋白伤口敷料

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.

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