Not Cleared Direct

DEN210045 - APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210045 · Apollo Endosurgery, Inc. · Gastroenterology & Urology device
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Jul 2022
Decision
285d
Days
Class 2
Risk

DEN210045 is an FDA 510(k) submission (not cleared) for the APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE .... Classified as Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss (product code QTD), Class II - Special Controls.

Submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Not Cleared (DENG) decision on July 12, 2022 after a review of 285 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5983 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 285 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Apollo Endosurgery, Inc. devices

Submission Details

510(k) Number DEN210045 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 30, 2021
Decision Date July 12, 2022
Days to Decision 285 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 130d · This submission: 285d
Pathway characteristics

Device Classification

Product Code QTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5983
Definition This Endoscopic Device Uses Suturing To Approximate Gastric Tissue To Restrict The Volume Of The Stomach For The Intended Purpose Of Weight Loss.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.