Atlas FDA

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.

RecordFirmDate
in2 Smart (in2S) (K252809)Virility Medical , Ltd.2026-04-06
vPATCH (K223595)Virility Medical , Ltd.2023-05-01
vPatch (DEN210012)Virility Medical2021-11-23

Recalls involving this device

No recalls on record reference this clearance.