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FDA 510(k)

Gastro Concepts Air Assist

K-Number: K242668 · 2024-12-13

ApplicantGastro Concepts, LLC
Decision Date2024-12-13
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gastro Concepts Air Assist is the device name listed in this FDA 510(k) record. The listed applicant is Gastro Concepts, LLC. It received FDA 510(k) clearance on 2024-12-13 under 510(k) 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. The listed applicant is Gastro Concepts, LLC. The 510(k) number is K242668.

When did Gastro Concepts Air Assist receive FDA 510(k) clearance?

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

Who is the listed applicant for Gastro Concepts Air Assist?

The FDA 510(k) record lists Gastro Concepts, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: FER)

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.

K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)Haemoband Surgical, Ltd.K230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd.K200021Applied Medical AnoscopeApplied Medical ResourcesK171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.

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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