FDA 510(k)

UroLift 2 ATC Advanced Tissue Control System

K番号: K232558 · 2023-09-22

決定日2023-09-22

製品コードPEW

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

UroLift 2 ATC Advanced Tissue Control System is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K232558. The device is classified under product code PEW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the UroLift 2 ATC Advanced Tissue Control System?

UroLift 2 ATC Advanced Tissue Control System is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Neotract, Inc.. The 510(k) number is K232558.

When did UroLift 2 ATC Advanced Tissue Control System receive FDA 510(k) clearance?

UroLift 2 ATC Advanced Tissue Control System received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232558.

Who is the listed applicant for UroLift 2 ATC Advanced Tissue Control System?

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

What is the FDA product code for UroLift 2 ATC Advanced Tissue Control System?

The FDA product code for UroLift 2 ATC Advanced Tissue Control System is PEW.

申請者としてNeotract, Inc.を記載するその他の記録

K212396UroLift System Rigid Retrieval Kit Sterilization Tray K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge K200441UroLift Advanced Tissue Control (ATC) System K192781UroLift System Procedure Kit Sterilization Tray K193269UroLift System (UL400)K190377UroLift System UL400

すべての11件のデバイスを表示 →

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。