in2 Smart (in2S)— 510(k) K252809
Substantially EquivalentVirility Medical , Ltd.
FDA 510(k) clearance K252809 for in2 Smart (in2S), Substantially Equivalent on 2026-04-06. Applicant: Virility Medical , Ltd.. Device class: 2.
Summary
Virility Medical's in2 Smart (in2S) is filed under product code QRC (Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 876.5026. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Virility Medical filed from Hod Hasharon, Israel. The decision came 215 calendar days after FDA received it (September 3, 2025 to April 6, 2026).
Clearance details
- Applicant
- Virility Medical , Ltd.
- Product code
- Product code QRC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5026
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hod Hasharon, IL
Recent devices under product code QRC
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