MOR
FDA 510(k) clearance K241897 · decided 2025-02-11
Clearance details
- K-number
- K241897
- Device name
- MOR
- Applicant
- Morari, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-28
- Decision date
- 2025-02-11
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- QRC
- Device class
- 2
- Regulation number
- 876.5026
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- 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 |
| 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.