FDA 510(k)

ビーエーメッドレーザー手術糸

K番号: K232769 · 2023-12-06

申請者Bt Beamedical Tachnoogies Ltd. (Beamed)

決定日2023-12-06

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

BeaMed Laser Surgery Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Bt Beamedical Tachnoogies Ltd. (Beamed). It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K232769. 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.

よくある質問

What is the BeaMed Laser Surgery Fibers?

BeaMed Laser Surgery Fibers is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Bt Beamedical Tachnoogies Ltd. (Beamed). The 510(k) number is K232769.

When did BeaMed Laser Surgery Fibers receive FDA 510(k) clearance?

BeaMed Laser Surgery Fibers received FDA 510(k) clearance on 2023-12-06, under 510(k) number K232769.

Who is the listed applicant for BeaMed Laser Surgery Fibers?

The FDA 510(k) record lists Bt Beamedical Tachnoogies Ltd. (Beamed) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeaMed Laser Surgery Fibers?

The FDA product code for BeaMed Laser Surgery Fibers is GEX. This falls under the Gastroenterology category.

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ビーエーメッドレーザー手術糸

医療機器の概要

よくある質問

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