FDA 510(k)

in2 Smart (in2S)

K-Number: K252809 · 2026-04-06

Decision Date2026-04-06

Product CodeQRC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Virility Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223595vPATCH

Related Devices (Code: QRC)

K241897MORMorari, Inc.K223595vPATCHVirility Medical , Ltd.

Official Source

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