FDA 510(k)

in2智能（in2S）

K号: K252809 · 2026-04-06

决定日期2026-04-06

产品代码QRC

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决定实质等同

器械摘要

in2 Smart (in2S) is the device name listed in this FDA 510(k) record. The listed applicant is Virility Medical , Ltd.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K252809. The device is classified under product code QRC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the in2 Smart (in2S)?

in2 Smart (in2S) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Virility Medical , Ltd.. The 510(k) number is K252809.

When did in2 Smart (in2S) receive FDA 510(k) clearance?

in2 Smart (in2S) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K252809.

Who is the listed applicant for in2 Smart (in2S)?

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

What is the FDA product code for in2 Smart (in2S)?

The FDA product code for in2 Smart (in2S) is QRC.

列明Virility Medical , Ltd.为申报人的其他记录

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