FDA 510(k)

Hawkeye 控制單元配合 Eyas 眼鏡式內視鏡

K 號：K233115 · 2024-02-06

決定日期2024-02-06

產品代碼HRX

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器材摘要

Hawkeye Control Unit with Eyas Endoscope is the device name listed in this FDA 510(k) record. The listed applicant is E Surgical, LLC. It received FDA 510(k) clearance on 2024-02-06 under 510(k) number K233115. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hawkeye Control Unit with Eyas Endoscope?

Hawkeye Control Unit with Eyas Endoscope is a medical device that received FDA 510(k) clearance on 2024-02-06. The listed applicant is E Surgical, LLC. The 510(k) number is K233115.

When did Hawkeye Control Unit with Eyas Endoscope receive FDA 510(k) clearance?

Hawkeye Control Unit with Eyas Endoscope received FDA 510(k) clearance on 2024-02-06, under 510(k) number K233115.

Who is the listed applicant for Hawkeye Control Unit with Eyas Endoscope?

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

What is the FDA product code for Hawkeye Control Unit with Eyas Endoscope?

The FDA product code for Hawkeye Control Unit with Eyas Endoscope is HRX.

其他以 E Surgical, LLC 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。

K231126Eblator 裝置

相關器械（代碼：HRX）

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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