FDA 510(k)

星光內視鏡導管

K 號：K243016 · 2025-03-20

決定日期2025-03-20

產品代碼NQQ

諮詢委員會RA

決定相當於

器材摘要

Starlight Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K243016. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Starlight Imaging Catheter?

Starlight Imaging Catheter is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Spectrawave, Inc.. The 510(k) number is K243016.

When did Starlight Imaging Catheter receive FDA 510(k) clearance?

Starlight Imaging Catheter received FDA 510(k) clearance on 2025-03-20, under 510(k) number K243016.

Who is the listed applicant for Starlight Imaging Catheter?

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

What is the FDA product code for Starlight Imaging Catheter?

The FDA product code for Starlight Imaging Catheter is NQQ.

其他以 Spectrawave, Inc. 為申請人之記錄

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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相關器械（代碼：NQQ）

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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