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FDA 510(k)

HESTIA (L200-A)

K-Number: K242946 · 2025-10-03

ApplicantSenbitec Co., Ltd.
Decision Date2025-10-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HESTIA (L200-A) is the device name listed in this FDA 510(k) record. The listed applicant is Senbitec Co., Ltd.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K242946. 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 HESTIA (L200-A)?

HESTIA (L200-A) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Senbitec Co., Ltd.. The 510(k) number is K242946.

When did HESTIA (L200-A) receive FDA 510(k) clearance?

HESTIA (L200-A) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K242946.

Who is the listed applicant for HESTIA (L200-A)?

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

What is the FDA product code for HESTIA (L200-A)?

The FDA product code for HESTIA (L200-A) 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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