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FDA 510(k)

內視鏡尖端保護器 - 無菌，內視鏡尖端保護器 - 非无菌

K 號：K191715 · 2020-01-27

申請人STERIS Corporation
決定日期2020-01-27
產品代碼OCU
諮詢委員會GU
決定相當於

器材摘要

Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2020-01-27 under 510(k) number K191715. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile?

Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile is a medical device that received FDA 510(k) clearance on 2020-01-27. The listed applicant is STERIS Corporation. The 510(k) number is K191715.

When did Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile receive FDA 510(k) clearance?

Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile received FDA 510(k) clearance on 2020-01-27, under 510(k) number K191715.

Who is the listed applicant for Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile?

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

What is the FDA product code for Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile?

The FDA product code for Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile is OCU.

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相關器械（代碼：OCU）

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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