510(k) clearances

MOR

Morari, Inc. · Gastroenterology, Urology

K241897Substantially EquivalentTraditionalQRC
Open FDA's page for this record
Third party flag
N
City
Maple Grove
Advisory committee description
Gastroenterology, Urology
Address 1
6501 Zircon Ln.
Statement or summary
Summary
Product code
QRC
Zip code
55311
Applicant
Morari, Inc.
Decision date
2025-02-11
Decision code
SESE
Country code
US
Device name
MOR
Advisory committee
GU
Contact
Jeff Bennett
K number
K241897
State
MN
Date received
2024-06-28
Review advisory committee
GU
Postal code
55311
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5026
Device class
2
Registration number
3020659203, 3017709633, 3014536907
FEI number
3020659203, 3017709633, 3014536907
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.