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FDA 510(k)

Apollo ESG NXT System, Apollo REVISE NXT System

K-Number: K232544 · 2023-09-18

ApplicantApollo Endosurgery, Inc.
Decision Date2023-09-18
Product CodeQTD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Apollo ESG NXT System, Apollo REVISE NXT System is a medical device manufactured by Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2023-09-18 under approval number K232544. The device is classified under product code QTD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apollo ESG NXT System, Apollo REVISE NXT System?

Apollo ESG NXT System, Apollo REVISE NXT System is a medical device that received FDA 510(k) clearance on 2023-09-18. It is manufactured by Apollo Endosurgery, Inc.. The 510(k) number is K232544.

When was Apollo ESG NXT System, Apollo REVISE NXT System approved by the FDA?

Apollo ESG NXT System, Apollo REVISE NXT System received FDA 510(k) clearance on 2023-09-18, under approval number K232544.

What company makes Apollo ESG NXT System, Apollo REVISE NXT System?

Apollo ESG NXT System, Apollo REVISE NXT System is manufactured by Apollo Endosurgery, Inc..

What is the FDA product code for Apollo ESG NXT System, Apollo REVISE NXT System?

The FDA product code for Apollo ESG NXT System, Apollo REVISE NXT System is QTD.

Related Clinical Trials

NCT05308706 Efficacy of the Apollo System for Children With ADHD ACTIVE_NOT_RECRUITING

Other Devices by Apollo Endosurgery, Inc.

K171886OverStitch SX Endoscopic Suturing System (ESS) K201808X-Tack Endoscopic HeliX Tacking System K210266OverStitch Sx Endoscopic Suturing System DEN210045APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System K231553OverStitch NXT Endoscopic Suturing System

Related Devices (Code: QTD)

DEN210045APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX SystemApollo Endosurgery, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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