FDA 510(k)

Optilume® 高圧尿科バルーン拡張カテーテル

K番号: K250910 · 2025-05-22

決定日2025-05-22

製品コードEZN

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

Optilume® High Pressure Urological Balloon Dilation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Urotronic, Inc.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K250910. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Optilume® High Pressure Urological Balloon Dilation Catheter?

Optilume® High Pressure Urological Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Urotronic, Inc.. The 510(k) number is K250910.

When did Optilume® High Pressure Urological Balloon Dilation Catheter receive FDA 510(k) clearance?

Optilume® High Pressure Urological Balloon Dilation Catheter received FDA 510(k) clearance on 2025-05-22, under 510(k) number K250910.

Who is the listed applicant for Optilume® High Pressure Urological Balloon Dilation Catheter?

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

What is the FDA product code for Optilume® High Pressure Urological Balloon Dilation Catheter?

The FDA product code for Optilume® High Pressure Urological Balloon Dilation Catheter is EZN.

申請者としてUrotronic, Inc.を記載するその他の記録

K191061Optilume Basic 尿科バルーン拡張カテーテル

公式ソース

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