FDA 510(k)

公洞锐器容器（SCR-01Q，SCR-01G，SCR-03G）

K号: K253222 · 2025-12-22

申请人Zhejiang Gongdong Medical Technology Co., Ltd.

决定日期2025-12-22

产品代码MMK

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

Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Gongdong Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) number K253222. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)?

Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Zhejiang Gongdong Medical Technology Co., Ltd.. The 510(k) number is K253222.

When did Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) receive FDA 510(k) clearance?

Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) received FDA 510(k) clearance on 2025-12-22, under 510(k) number K253222.

Who is the listed applicant for Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)?

The FDA 510(k) record lists Zhejiang Gongdong Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)?

The FDA product code for Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) is MMK.

列明Zhejiang Gongdong Medical Technology Co., Ltd.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。

K220739一次性尿液收集管 K201523锐器容器

相关器械（代码：MMK）

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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