FDA 510(k)

UroLift System (UL400 and UL500)

K番号: K173087 · 2017-12-28

決定日2017-12-28

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 System (UL400 and UL500) is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2017-12-28 under 510(k) number K173087. 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 and UL500)?

UroLift System (UL400 and UL500) is a medical device that received FDA 510(k) clearance on 2017-12-28. The listed applicant is Neotract, Inc.. The 510(k) number is K173087.

When did UroLift System (UL400 and UL500) receive FDA 510(k) clearance?

UroLift System (UL400 and UL500) received FDA 510(k) clearance on 2017-12-28, under 510(k) number K173087.

Who is the listed applicant for UroLift System (UL400 and UL500)?

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 and UL500)?

The FDA product code for UroLift System (UL400 and UL500) 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 K193269UroLift System (UL400)

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