meddevicedb.com FDA Device Reference

RELIZORB

DEN150001 Class II Direct
Decision Date
2015-11-20
Sponsor / Applicant
Alcresta, Inc.

Technical Specification

510(k) Submission ID DEN150001
Product Code PLQ
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5985
Decision Date 2015-11-20
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

RELIZORB received FDA 510(k) clearance under submission number DEN150001, sponsored by Alcresta, 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 2015-11-20.

Classification & Regulation

This clearance is catalogued under FDA product code PLQ and 21 CFR 876.5985, within the Gastroenterology, Urology review panel as a Class II device.