meddevicedb.com FDA Device Reference

ProdiGI

DEN220006 Class II Direct
Decision Date
2022-06-13
Sponsor / Applicant
Covidien, LLC

Technical Specification

510(k) Submission ID DEN220006
Product Code QSW
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.4410
Decision Date 2022-06-13
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

ProdiGI received FDA 510(k) clearance under submission number DEN220006, sponsored by Covidien, LLC. 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 2022-06-13.

Classification & Regulation

This clearance is catalogued under FDA product code QSW and 21 CFR 876.4410, within the Gastroenterology, Urology review panel as a Class II device.