vPATCH
FDA 510(k) clearance K223595 · decided 2023-05-01
Clearance details
- K-number
- K223595
- Device name
- vPATCH
- Applicant
- Virility Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-02
- Decision date
- 2023-05-01
- Days to decision
- 150 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 |
|---|---|---|
| in2 Smart (in2S) (K252809) | Virility Medical , Ltd. | 2026-04-06 |
| MOR (K241897) | Morari, Inc. | 2025-02-11 |
| vPatch (DEN210012) | Virility Medical | 2021-11-23 |
Recalls involving this device
No recalls on record reference this clearance.