FDA 510(k)

RIVOS™ EUS進入設備（M00553900）

K 號：K260428 · 2026-06-17

決定日期2026-06-17

產品代碼ODG

諮詢委員會GU

決定相當於

器材摘要

RIVOS™ EUS Access Device (M00553900) 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 2026-06-17 under 510(k) number K260428. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RIVOS™ EUS Access Device (M00553900)?

RIVOS™ EUS Access Device (M00553900) is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K260428.

When did RIVOS™ EUS Access Device (M00553900) receive FDA 510(k) clearance?

RIVOS™ EUS Access Device (M00553900) received FDA 510(k) clearance on 2026-06-17, under 510(k) number K260428.

Who is the listed applicant for RIVOS™ EUS Access Device (M00553900)?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for RIVOS™ EUS Access Device (M00553900)?

The FDA product code for RIVOS™ EUS Access Device (M00553900) is ODG.

其他以 Boston Scientific Corporation 為申請人之記錄

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相關器械（代碼：ODG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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