FDA 510(k)

プロディオン尿道被覆システム

K番号: K252572 · 2025-10-07

決定日2025-10-07

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

決定大幅同等

医療機器の概要

Prodeon Urethral Sheath System is the device name listed in this FDA 510(k) record. The listed applicant is Prodeon Medical, Inc.. It received FDA 510(k) clearance on 2025-10-07 under 510(k) number K252572. 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 Prodeon Urethral Sheath System?

Prodeon Urethral Sheath System is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Prodeon Medical, Inc.. The 510(k) number is K252572.

When did Prodeon Urethral Sheath System receive FDA 510(k) clearance?

Prodeon Urethral Sheath System received FDA 510(k) clearance on 2025-10-07, under 510(k) number K252572.

Who is the listed applicant for Prodeon Urethral Sheath System?

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

What is the FDA product code for Prodeon Urethral Sheath System?

The FDA product code for Prodeon Urethral Sheath System is FED.

申請者としてProdeon Medical, Inc.を記載するその他の記録

K261342Urocross Expander System (UES-2018-C1)K253525Urocross Expander System (Model Numbers ES2018 and ES3025)

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