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FDA 510(k)

Precision GI

K-Number: K231422 · 2023-08-28

ApplicantLimaca Medical, Ltd.
Decision Date2023-08-28
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Precision GI is a medical device manufactured by Limaca Medical, Ltd.. It received FDA 510(k) clearance on 2023-08-28 under approval number K231422. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision GI?

Precision GI is a medical device that received FDA 510(k) clearance on 2023-08-28. It is manufactured by Limaca Medical, Ltd.. The 510(k) number is K231422.

When was Precision GI approved by the FDA?

Precision GI received FDA 510(k) clearance on 2023-08-28, under approval number K231422.

What company makes Precision GI?

Precision GI is manufactured by Limaca Medical, Ltd..

What is the FDA product code for Precision GI?

The FDA product code for Precision GI is FCG.

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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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