FDA 510(k)

翠龍滲透系統

K 號：K163507 · 2017-04-25

決定日期2017-04-25

產品代碼PBZ

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Triton Sponge System is the device name listed in this FDA 510(k) record. The listed applicant is Gauss Surgical, Inc.,. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K163507. The device is classified under product code PBZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Triton Sponge System?

Triton Sponge System is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Gauss Surgical, Inc.,. The 510(k) number is K163507.

When did Triton Sponge System receive FDA 510(k) clearance?

Triton Sponge System received FDA 510(k) clearance on 2017-04-25, under 510(k) number K163507.

Who is the listed applicant for Triton Sponge System?

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

What is the FDA product code for Triton Sponge System?

The FDA product code for Triton Sponge System is PBZ.

其他以 Gauss Surgical, 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。

K160338翠龍系統

相關器械（代碼：PBZ）

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。

K252282SurgiCount+ 系統Stryker Instruments K232250SurgiCount+ 系統Stryker Instruments K160338翠龍系統Gauss Surgical, Inc.,

官方來源

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