DeviceClearance

Product code QUD— Gastroenterology, Urology

Pill Sense System

Classification name
Blood Detection Capsule
Device class
Class 2
Regulation
21 CFR 876.1390
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QUD under 21 CFR 876.1390, via openFDA

Market context for product code QUD

FDA has cleared 1 device under product code QUD, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QUD

Recent clearances under product code QUD

Data sourced from openFDA. This site is unofficial and independent of the FDA.