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

Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

Apollo Endosurgery, Inc.

The following data is part of a De Novo classification by Apollo Endosurgery, Inc. with the FDA for Apollo Esg System, Apollo Esg Sx System, Apollo Revise System, Apollo Revise Sx System.

Pre-market Notification Details

DeNovo IDDEN210045
Device Name:APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
ClassificationEndoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Applicant Apollo Endosurgery, Inc. 1120 S. Capital Of Texas Hwy., Bldg 1, Ste 300 Austin,  TX  78746
ContactDavid M. Hooper
Product CodeQTD  
CFR Regulation Number876.5983 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2021-09-30
Decision Date2022-07-12
Reclassification Order:Reclassification Order

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