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FDA 510(k)

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)

K-Number: K241643 · 2025-02-14

ApplicantWontech Co., Ltd.
Decision Date2025-02-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) 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 2025-02-14 under 510(k) number K241643. 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 WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)?

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K241643.

When did WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) receive FDA 510(k) clearance?

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) received FDA 510(k) clearance on 2025-02-14, under 510(k) number K241643.

Who is the listed applicant for WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)?

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 WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)?

The FDA product code for WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) 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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