meddevicedb.com FDA Device Reference

CARPEDIEM System

DEN180055 Class II Direct
Decision Date
2020-04-29
Sponsor / Applicant
Bellco Srl (Now Part of Medtronic, Inc)

Technical Specification

510(k) Submission ID DEN180055
Product Code QIR
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5861
Decision Date 2020-04-29
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

CARPEDIEM System received FDA 510(k) clearance under submission number DEN180055, sponsored by Bellco Srl (Now Part of Medtronic, Inc). 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 2020-04-29.

Classification & Regulation

This clearance is catalogued under FDA product code QIR and 21 CFR 876.5861, within the Gastroenterology, Urology review panel as a Class II device.