in2 Smart (in2S)
K-Number: K252809 · 2026-04-06
ApplicantVirility Medical , Ltd.
Decision Date2026-04-06
Product CodeQRC
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
in2 Smart (in2S) is a medical device manufactured by Virility Medical , Ltd.. It received FDA 510(k) clearance on 2026-04-06 under approval 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. It is manufactured by Virility Medical , Ltd.. The 510(k) number is K252809.
When was in2 Smart (in2S) approved by the FDA?
in2 Smart (in2S) received FDA 510(k) clearance on 2026-04-06, under approval number K252809.
What company makes in2 Smart (in2S)?
in2 Smart (in2S) is manufactured by Virility Medical , Ltd..
What is the FDA product code for in2 Smart (in2S)?
The FDA product code for in2 Smart (in2S) is QRC.
Other Devices by Virility Medical , Ltd.
Related Devices (Code: QRC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.