FDA 510(k)

SurgiCount+ System

K号: K252282 · 2026-03-16

决定日期2026-03-16

产品代码PBZ

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

SurgiCount+ System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K252282. The device is classified under product code PBZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SurgiCount+ System?

SurgiCount+ System is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Stryker Instruments. The 510(k) number is K252282.

When did SurgiCount+ System receive FDA 510(k) clearance?

SurgiCount+ System received FDA 510(k) clearance on 2026-03-16, under 510(k) number K252282.

Who is the listed applicant for SurgiCount+ System?

FDA 510(k)记录中列出Stryker Instruments为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for SurgiCount+ System?

The FDA product code for SurgiCount+ System is PBZ.

列明Stryker Instruments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。

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官方来源

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