FDA 510(k)

NPseal

K号: K251156 · 2025-05-15

决定日期2025-05-15

产品代码OKO

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决定实质等同

器械摘要

NPseal is the device name listed in this FDA 510(k) record. The listed applicant is Guard Medical, Inc.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K251156. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NPseal?

NPseal is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Guard Medical, Inc.. The 510(k) number is K251156.

When did NPseal receive FDA 510(k) clearance?

NPseal received FDA 510(k) clearance on 2025-05-15, under 510(k) number K251156.

Who is the listed applicant for NPseal?

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

What is the FDA product code for NPseal?

The FDA product code for NPseal is OKO.

列明Guard Medical, 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。

K250708NPseal K241522NPseal (20和25)K240244NPseal (小、中、大)K212971NPseal K211130NPseal K200305NPseal

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官方来源

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