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FDA 510(k)

ConvaVAC™ 负压伤口治疗系统

K号: K253263 · 2026-06-24

决定日期2026-06-24
产品代码OMP
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决定实质等同

器械摘要

ConvaVAC™ Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited, Gdc Building. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K253263. 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 ConvaVAC™ Negative Pressure Wound Therapy System?

ConvaVAC™ Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Convatec Limited, Gdc Building. The 510(k) number is K253263.

When did ConvaVAC™ Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

ConvaVAC™ Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2026-06-24, under 510(k) number K253263.

Who is the listed applicant for ConvaVAC™ Negative Pressure Wound Therapy System?

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

What is the FDA product code for ConvaVAC™ Negative Pressure Wound Therapy System?

The FDA product code for ConvaVAC™ Negative Pressure Wound Therapy System is OMP.

相关临床试验

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相关器械(代码:OMP)

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。

官方来源

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