FDA 510(k)

VERSA 负压伤口治疗系统（VCMPP-100）

K号: K241061 · 2024-08-21

决定日期2024-08-21

产品代码OMP

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决定实质等同

器械摘要

VERSA Negative Pressure Wound Therapy System (VCMPP-100) is the device name listed in this FDA 510(k) record. The listed applicant is Cork Medical. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K241061. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VERSA Negative Pressure Wound Therapy System (VCMPP-100)?

VERSA Negative Pressure Wound Therapy System (VCMPP-100) is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Cork Medical. The 510(k) number is K241061.

When did VERSA Negative Pressure Wound Therapy System (VCMPP-100) receive FDA 510(k) clearance?

VERSA Negative Pressure Wound Therapy System (VCMPP-100) received FDA 510(k) clearance on 2024-08-21, under 510(k) number K241061.

Who is the listed applicant for VERSA Negative Pressure Wound Therapy System (VCMPP-100)?

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

What is the FDA product code for VERSA Negative Pressure Wound Therapy System (VCMPP-100)?

The FDA product code for VERSA Negative Pressure Wound Therapy System (VCMPP-100) is OMP.

列明Cork Medical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。

K261291Nisus NPWT 罐 500-毫升 (CPC-500)K243187Nisus ONE 负压伤口治疗系统 (OCMPP-100)K230677Cork Medical VERSA 负压伤口系统 (VCMPP-100)

官方来源

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