FDA 510(k)

Marigen Wound Extra; Kerecis 硅胶; Kerecis Parvus

K号: K251845 · 2025-07-16

决定日期2025-07-16

产品代码KGN

决定实质等同

器械摘要

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2025-07-16 under 510(k) number K251845. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus?

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Kerecis Limited. The 510(k) number is K251845.

When did Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus receive FDA 510(k) clearance?

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus received FDA 510(k) clearance on 2025-07-16, under 510(k) number K251845.

Who is the listed applicant for Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus?

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

What is the FDA product code for Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus?

The FDA product code for Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus is KGN.

列明Kerecis Limited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。

K251844Kerecis SurgiBind (50241)K243843Tendon Protect (50242)K241080Kerecis Parvus (50207)K213231Kerecis 硅胶 K202430Kerecis 重建 K192612Kerecis 牙龈移植

查看所有 9 个设备 →

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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