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FDA 510(k)

Air Gap Fiber

K-Number: K232106 · 2024-01-08

ApplicantWontech Co., Ltd.
Decision Date2024-01-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Air Gap Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Wontech Co., Ltd.. It received FDA 510(k) clearance on 2024-01-08 under 510(k) number K232106. 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 Air Gap Fiber?

Air Gap Fiber is a medical device that received FDA 510(k) clearance on 2024-01-08. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K232106.

When did Air Gap Fiber receive FDA 510(k) clearance?

Air Gap Fiber received FDA 510(k) clearance on 2024-01-08, under 510(k) number K232106.

Who is the listed applicant for Air Gap Fiber?

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

What is the FDA product code for Air Gap Fiber?

The FDA product code for Air Gap Fiber is GEX. This falls under the Gastroenterology category.

Other records listing Wontech Co., Ltd. as applicant

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Related Devices (Code: GEX)

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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