FDA 510(k)

PAL多用途导管和PAL手动棒

K号: K171286 · 2017-10-13

决定日期2017-10-13

产品代码QPB

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决定实质等同

器械摘要

PAL Multi-Use Cannulas and PAL Manual Wand is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K171286. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PAL Multi-Use Cannulas and PAL Manual Wand?

PAL Multi-Use Cannulas and PAL Manual Wand is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Microaire Surgical Instruments, LLC. The 510(k) number is K171286.

When did PAL Multi-Use Cannulas and PAL Manual Wand receive FDA 510(k) clearance?

PAL Multi-Use Cannulas and PAL Manual Wand received FDA 510(k) clearance on 2017-10-13, under 510(k) number K171286.

Who is the listed applicant for PAL Multi-Use Cannulas and PAL Manual Wand?

The FDA 510(k) record lists Microaire Surgical Instruments, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAL Multi-Use Cannulas and PAL Manual Wand?

The FDA product code for PAL Multi-Use Cannulas and PAL Manual Wand is QPB.

列明Microaire Surgical Instruments, LLC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。

K243589PAL灭菌盒 K244026PAL 7020控制台 K242804PAL吸引系统 K220318PAL浸润系统 K212024PAL系统 K181819SMARTRELEASE 内窥镜软组织释放系统

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官方来源

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