FDA Product Code QTN: Orally Ingested Transient Device For Constipation
An Orally Ingested Transient Device For Constipation Is An Electric Swallowable Capsule That Naturally Passes Through The Gastrointestinal Tract For The Treatment Of Constipation.
Leading manufacturers include Vibrant, Ltd..
3
Total
2
Cleared
154d
Avg days
2022
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Orally Ingested Transient Device For Constipation Devices (Product Code QTN)
3 devices
Cleared
Dec 08, 2023
Vibrant System
Vibrant, Ltd.
Gastroenterology & Urology
86d
Cleared
Jan 13, 2023
Vibrant System
Vibrant, Ltd.
Gastroenterology & Urology
106d
Not Cleared
Aug 26, 2022
Vibrant System
Vibrant, Ltd.
Gastroenterology & Urology
269d
About Product Code QTN - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QTN since 2022, with 2 receiving FDA clearance (average review time: 154 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
QTN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →