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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 the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2023-09-18 under 510(k) 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. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K232544.

When did Apollo ESG NXT System, Apollo REVISE NXT System receive FDA 510(k) clearance?

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

Who is the listed applicant for Apollo ESG NXT System, Apollo REVISE NXT System?

The FDA 510(k) record lists Apollo Endosurgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Apollo Endosurgery, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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