FDA 510(k)

SurgiAid Collagen Wound Dressing (HA)

K号: K242100 · 2025-10-16

决定日期2025-10-16

产品代码KGN

决定实质等同

器械摘要

SurgiAid Collagen Wound Dressing (HA) 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 2025-10-16 under 510(k) number K242100. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the SurgiAid Collagen Wound Dressing (HA)?

SurgiAid Collagen Wound Dressing (HA) is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Maxigen Biotech, Inc.. The 510(k) number is K242100.

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

SurgiAid Collagen Wound Dressing (HA) received FDA 510(k) clearance on 2025-10-16, under 510(k) number K242100.

Who is the listed applicant for SurgiAid Collagen Wound Dressing (HA)?

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 (HA)?

The FDA product code for SurgiAid Collagen Wound Dressing (HA) 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）K230529HealiAid 牙科胶原蛋白伤口敷料 K223126SurgiAid® Collagen Wound Dressing

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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