vPatch
FDA 510(k) clearance DEN210012 · decided 2021-11-23
Clearance details
- K-number
- DEN210012
- Device name
- vPatch
- Applicant
- Virility Medical
- Decision
- Unknown
- Date received
- 2021-03-30
- Decision date
- 2021-11-23
- Days to decision
- 238 days
- Clearance type
- Direct
- 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 (K223595) | Virility Medical , Ltd. | 2023-05-01 |
Recalls involving this device
No recalls on record reference this clearance.