APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System— 510(k) DEN210045

Name: FDA 510(k) clearance DEN210045
Creator: U.S. Food and Drug Administration
Published: 2022-07-12

Unknown

Apollo Endosurgery, Inc.

FDA 510(k) clearance DEN210045 for APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System, Unknown on 2022-07-12. Applicant: Apollo Endosurgery, Inc.. Device class: 2.

Clearance details

Applicant: Apollo Endosurgery, Inc.
Product code: Code QTD
Device class: Class 2
Regulation: 21 CFR 876.5983
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-30
Decision date: 2022-07-12
Decision: Unknown
Clearance type: Direct
Location: Austin, TX, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.