FDA 510(k)

Navigator™ Flex Ureteral Access Sheath Set

K番号: K261915 · 2026-08-04

決定日2026-08-04

製品コードFED

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

Navigator™ Flex Ureteral Access Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-08-04 under 510(k) number K261915. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Navigator™ Flex Ureteral Access Sheath Set?

Navigator™ Flex Ureteral Access Sheath Set is a medical device that received FDA 510(k) clearance on 2026-08-04. The listed applicant is Boston Scientific Corporation. The 510(k) number is K261915.

When did Navigator™ Flex Ureteral Access Sheath Set receive FDA 510(k) clearance?

Navigator™ Flex Ureteral Access Sheath Set received FDA 510(k) clearance on 2026-08-04, under 510(k) number K261915.

Who is the listed applicant for Navigator™ Flex Ureteral Access Sheath Set?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navigator™ Flex Ureteral Access Sheath Set?

The FDA product code for Navigator™ Flex Ureteral Access Sheath Set is FED.

申請者としてBoston Scientific Corporationを記載するその他の記録

K262151SpaceOAR Flex™ System K261153LithoVue Elite Digital Flexible Ureteroscope System K262165FARADRIVE™ ステアブルシート（M004PF21M402）K262462TheraSphere 360™ Y-90 Management Platform K261488OBSIDIO Conformable Embolic K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

すべての167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。