FDA.report

510(k) K223031

Device
Vibrant System
Applicant
Vibrant, Ltd.
510(k) number
K223031
Product code
QTN
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-13
Date received
2022-09-29
Regulation
876.5940
Classification name
Orally Ingested Transient Device For Constipation
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Martha Bezalel
Address
Hakochav P.O. Box 516 Yokneam IL 2069206 2069206

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QTN

510(k)DeviceApplicantDecision date
K232830Vibrant SystemVibrant, Ltd.2023-12-08
DEN210052Vibrant SystemVibrant, Ltd.2022-08-26