meddevicedb.com FDA Device Reference

Pill Sense System

DEN220065 Class II Direct
Decision Date
2023-02-24
Sponsor / Applicant
Enterasense , Ltd.

Technical Specification

510(k) Submission ID DEN220065
Product Code QUD
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1390
Decision Date 2023-02-24
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Pill Sense System received FDA 510(k) clearance under submission number DEN220065, sponsored by Enterasense , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-02-24.

Classification & Regulation

This clearance is catalogued under FDA product code QUD and 21 CFR 876.1390, within the Gastroenterology, Urology review panel as a Class II device.