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FDA 510(k)

GERDX-System

K-Number: K233240 · 2024-06-21

ApplicantG-Surg GmbH
Decision Date2024-06-21
Product CodeODE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GERDX-System is a medical device manufactured by G-Surg GmbH. It received FDA 510(k) clearance on 2024-06-21 under approval number K233240. The device is classified under product code ODE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GERDX-System?

GERDX-System is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by G-Surg GmbH. The 510(k) number is K233240.

When was GERDX-System approved by the FDA?

GERDX-System received FDA 510(k) clearance on 2024-06-21, under approval number K233240.

What company makes GERDX-System?

GERDX-System is manufactured by G-Surg GmbH.

What is the FDA product code for GERDX-System?

The FDA product code for GERDX-System is ODE.

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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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