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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
510(k) Number K232544
Device Name Apollo ESG NXT System, Apollo REVISE NXT System
Applicant
Apollo Endosurgery, Inc.
1120 S. Capital Of Texas Hwy., Suite 300
Austin,  TX  78746
Applicant Contact James Shene
Correspondent
Apollo Endosurgery, Inc.
1120 S. Capital Of Texas Hwy., Suite 300
Austin,  TX  78746
Correspondent Contact James Shene
Classification Product Code
QTD  
Date Received08/22/2023
Decision Date 09/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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