FDA 510(k)

Single Use Ureteral Access Sheath

K番号: K260410 · 2026-09-11

申請者Zhejiang Chuangxiang Medical Technology Co., Ltd.

決定日2026-09-11

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

Single Use Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K260410. 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 Single Use Ureteral Access Sheath?

Single Use Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K260410.

When did Single Use Ureteral Access Sheath receive FDA 510(k) clearance?

Single Use Ureteral Access Sheath received FDA 510(k) clearance on 2026-09-11, under 510(k) number K260410.

Who is the listed applicant for Single Use Ureteral Access Sheath?

The FDA 510(k) record lists Zhejiang Chuangxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Ureteral Access Sheath?

The FDA product code for Single Use Ureteral Access Sheath is FED.

申請者としてZhejiang Chuangxiang Medical Technology Co., Ltd.を記載するその他の記録

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公式ソース

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