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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 the device name listed in this FDA 510(k) record. The listed applicant is Limaca Medical, Ltd.. It received FDA 510(k) clearance on 2023-08-28 under 510(k) 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. The listed applicant is Limaca Medical, Ltd.. The 510(k) number is K231422.

When did Precision GI receive FDA 510(k) clearance?

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

Who is the listed applicant for Precision GI?

The FDA 510(k) record lists Limaca Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision GI?

The FDA product code for Precision GI is FCG.

Related Devices (Code: FCG)

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.

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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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