FDA 510(k)

UroLift System (UL400)

K番号: K193269 · 2019-12-20

決定日2019-12-20

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Substantially Equivalent

医療機器の概要

UroLift System (UL400) is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193269. 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 System (UL400)?

UroLift System (UL400) is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Neotract, Inc.. The 510(k) number is K193269.

When did UroLift System (UL400) receive FDA 510(k) clearance?

UroLift System (UL400) received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193269.

Who is the listed applicant for UroLift System (UL400)?

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 System (UL400)?

The FDA product code for UroLift System (UL400) is PEW.

申請者としてNeotract, Inc.を記載するその他の記録

K232558UroLift 2 ATC Advanced Tissue Control System 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 K190377UroLift System UL400

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公式ソース

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