FDA 510(k)

水溶性コートされた単回使用用ナラトンカテーテル（NCR）

K番号: K260394 · 2026-06-24

決定日2026-06-24

製品コードEZD

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

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Jimushi Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K260394. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Hangzhou Jimushi Meditech Co., Ltd.. The 510(k) number is K260394.

When did Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) receive FDA 510(k) clearance?

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) received FDA 510(k) clearance on 2026-06-24, under 510(k) number K260394.

Who is the listed applicant for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

The FDA 510(k) record lists Hangzhou Jimushi Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

The FDA product code for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) is EZD.

申請者としてHangzhou Jimushi Meditech Co., Ltd.を記載するその他の記録

K222677単回使用用の間断型ネルタオンカテーテル K200134ジムシステリル尿道カテーテル（単回使用用）

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