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FDA 510(k)

CAPRI

K-Number: K254271 · 2026-02-26

ApplicantORO Co., Ltd.
Decision Date2026-02-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CAPRI is the device name listed in this FDA 510(k) record. The listed applicant is ORO Co., Ltd.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K254271. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPRI?

CAPRI is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is ORO Co., Ltd.. The 510(k) number is K254271.

When did CAPRI receive FDA 510(k) clearance?

CAPRI received FDA 510(k) clearance on 2026-02-26, under 510(k) number K254271.

Who is the listed applicant for CAPRI?

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

What is the FDA product code for CAPRI?

The FDA product code for CAPRI is GEX. This falls under the Gastroenterology category.

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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.

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