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FDA 510(k)

舒爾信組織標記

K 號：K230836 · 2024-01-23

申請人Surgmark GmbH
決定日期2024-01-23
產品代碼NEU
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

SchurSign Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Surgmark GmbH. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K230836. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SchurSign Tissue Marker?

SchurSign Tissue Marker is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Surgmark GmbH. The 510(k) number is K230836.

When did SchurSign Tissue Marker receive FDA 510(k) clearance?

SchurSign Tissue Marker received FDA 510(k) clearance on 2024-01-23, under 510(k) number K230836.

Who is the listed applicant for SchurSign Tissue Marker?

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

What is the FDA product code for SchurSign Tissue Marker?

The FDA product code for SchurSign Tissue Marker is NEU.

相關臨床試驗

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：NEU）

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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