FDA 510(k)

リソブラスト単回使用ホルミウムレーザーファイバー

K番号: K250776 · 2025-10-14

決定日2025-10-14

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

Lithoblast Single Use Holmium Laser Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Dawell Medical, LLC. It received FDA 510(k) clearance on 2025-10-14 under 510(k) number K250776. 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 Lithoblast Single Use Holmium Laser Fibers?

Lithoblast Single Use Holmium Laser Fibers is a medical device that received FDA 510(k) clearance on 2025-10-14. The listed applicant is Dawell Medical, LLC. The 510(k) number is K250776.

When did Lithoblast Single Use Holmium Laser Fibers receive FDA 510(k) clearance?

Lithoblast Single Use Holmium Laser Fibers received FDA 510(k) clearance on 2025-10-14, under 510(k) number K250776.

Who is the listed applicant for Lithoblast Single Use Holmium Laser Fibers?

The FDA 510(k) record lists Dawell Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lithoblast Single Use Holmium Laser Fibers?

The FDA product code for Lithoblast Single Use Holmium Laser Fibers is GEX. This falls under the Gastroenterology category.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

リソブラスト単回使用ホルミウムレーザーファイバー

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEX）

公式ソース