FDA 510(k)

Puracyn® Plus 抗菌冲洗溶液

K号: K232080 · 2024-05-31

决定日期2024-05-31

产品代码FRO

决定实质等同

器械摘要

Puracyn® Plus Antimicrobial Irrigation Solution is the device name listed in this FDA 510(k) record. The listed applicant is Innovacyn, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232080. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Puracyn® Plus Antimicrobial Irrigation Solution?

Puracyn® Plus Antimicrobial Irrigation Solution is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Innovacyn, Inc.. The 510(k) number is K232080.

When did Puracyn® Plus Antimicrobial Irrigation Solution receive FDA 510(k) clearance?

Puracyn® Plus Antimicrobial Irrigation Solution received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232080.

Who is the listed applicant for Puracyn® Plus Antimicrobial Irrigation Solution?

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

What is the FDA product code for Puracyn® Plus Antimicrobial Irrigation Solution?

The FDA product code for Puracyn® Plus Antimicrobial Irrigation Solution is FRO. This falls under the Anesthesiology category.

列明Innovacyn, 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。

K251757Puracyn® Plus 抗菌冲洗溶液

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