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 a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2024-01-08 under approval 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. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K232106.
When was Air Gap Fiber approved by the FDA?
Air Gap Fiber received FDA 510(k) clearance on 2024-01-08, under approval number K232106.
What company makes Air Gap Fiber?
Air Gap Fiber is manufactured by Wontech Co., Ltd..
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.
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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.