FDA 510(k)

cCeLL - 在体内使用Drop-In Robo（CN100-2W2C488775，CN100-1W1C775，DR200）

K号: K251852 · 2026-02-13

决定日期2026-02-13

产品代码OWN

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is the device name listed in this FDA 510(k) record. The listed applicant is VPIX Medical, Inc.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251852. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is VPIX Medical, Inc.. The 510(k) number is K251852.

When did cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) receive FDA 510(k) clearance?

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251852.

Who is the listed applicant for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

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

What is the FDA product code for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

The FDA product code for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is OWN.

列明VPIX 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。

K233391cCeLL - 在体

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。