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FDA 510(k)

Nexcore GI Insufflator

K-Number: K162332 · 2016-09-29

ApplicantNexcore Technology, LLC
Decision Date2016-09-29
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nexcore GI Insufflator is a medical device manufactured by Nexcore Technology, LLC. It received FDA 510(k) clearance on 2016-09-29 under approval number K162332. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nexcore GI Insufflator?

Nexcore GI Insufflator is a medical device that received FDA 510(k) clearance on 2016-09-29. It is manufactured by Nexcore Technology, LLC. The 510(k) number is K162332.

When was Nexcore GI Insufflator approved by the FDA?

Nexcore GI Insufflator received FDA 510(k) clearance on 2016-09-29, under approval number K162332.

What company makes Nexcore GI Insufflator?

Nexcore GI Insufflator is manufactured by Nexcore Technology, LLC.

What is the FDA product code for Nexcore GI Insufflator?

The FDA product code for Nexcore GI Insufflator is FCX.

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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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