FDA 510(k)

Gastro Concepts Air Assist

K-Number: K242668 · 2024-12-13

Decision Date2024-12-13

Product CodeFER

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Gastro Concepts Air Assist is a medical device manufactured by Gastro Concepts, LLC. It received FDA 510(k) clearance on 2024-12-13 under approval number K242668. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gastro Concepts Air Assist?

Gastro Concepts Air Assist is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by Gastro Concepts, LLC. The 510(k) number is K242668.

When was Gastro Concepts Air Assist approved by the FDA?

Gastro Concepts Air Assist received FDA 510(k) clearance on 2024-12-13, under approval number K242668.

What company makes Gastro Concepts Air Assist?

Gastro Concepts Air Assist is manufactured by Gastro Concepts, LLC.

What is the FDA product code for Gastro Concepts Air Assist?

The FDA product code for Gastro Concepts Air Assist is FER.

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Official Source

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