in2 Smart (in2S)
FDA 510(k) clearance K252809 · decided 2026-04-06
Clearance details
- K-number
- K252809
- Device name
- in2 Smart (in2S)
- Applicant
- Virility Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-03
- Decision date
- 2026-04-06
- Days to decision
- 215 days
- Clearance type
- Traditional
- Product code
- QRC
- Device class
- 2
- Regulation number
- 876.5026
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hod Hasharon, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MOR (K241897) | Morari, Inc. | 2025-02-11 |
| vPATCH (K223595) | Virility Medical , Ltd. | 2023-05-01 |
| vPatch (DEN210012) | Virility Medical | 2021-11-23 |
Recalls involving this device
No recalls on record reference this clearance.