Apollo ESG NXT System, Apollo REVISE NXT System— 510(k) K232544

Name: FDA 510(k) clearance K232544
Creator: U.S. Food and Drug Administration
Published: 2023-09-18

Substantially Equivalent

Apollo Endosurgery, Inc.

FDA 510(k) clearance K232544 for Apollo ESG NXT System, Apollo REVISE NXT System, Substantially Equivalent on 2023-09-18. 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: 2023-08-22
Decision date: 2023-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System2022-07-12

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K171886 — OverStitch SX Endoscopic Suturing System (ESS)2017-11-15
K122270 — OVERTUBE ENDOSCOPIC ACCESS SYSTEM2012-09-28

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