QUD · Class II · 21 CFR 876.1390

FDA Product Code QUD: Blood Detection Capsule

Ingestible Gastrointestinal Blood Detection Capsule Device Is A Prescription Device That Uses Spectrophotometry (light Absorption Technology) To Detect The Presence Or Absence Of Blood In The Gastrointestinal Tract.

Leading manufacturers include Enterasense , Ltd..

1
Total
0
Cleared
148d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Blood Detection Capsule Devices (Product Code QUD)

1 devices
1–1 of 1
Not Cleared Feb 24, 2023
Pill Sense System
DEN220065
Enterasense , Ltd.
Gastroenterology & Urology · 148d

About Product Code QUD - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QUD since 2023, with 0 receiving FDA clearance (average review time: 148 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QUD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →