meddevicedb.com FDA Device Reference

APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

DEN210045 Class II Direct
Decision Date
2022-07-12
Sponsor / Applicant
Apollo Endosurgery, Inc.

Technical Specification

510(k) Submission ID DEN210045
Product Code QTD
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5983
Decision Date 2022-07-12
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

APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System received FDA 510(k) clearance under submission number DEN210045, sponsored by Apollo Endosurgery, 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 2022-07-12.

Classification & Regulation

This clearance is catalogued under FDA product code QTD and 21 CFR 876.5983, within the Gastroenterology, Urology review panel as a Class II device.