FDA 510(k)

Traus SSG30 外科系統

K 號：K232938 · 2024-09-16

決定日期2024-09-16

產品代碼HBC

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Traus SSG30 Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2024-09-16 under 510(k) number K232938. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Traus SSG30 Surgical System?

Traus SSG30 Surgical System is a medical device that received FDA 510(k) clearance on 2024-09-16. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K232938.

When did Traus SSG30 Surgical System receive FDA 510(k) clearance?

Traus SSG30 Surgical System received FDA 510(k) clearance on 2024-09-16, under 510(k) number K232938.

Who is the listed applicant for Traus SSG30 Surgical System?

The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Traus SSG30 Surgical System?

The FDA product code for Traus SSG30 Surgical System is HBC.

其他以 Saeshin Precision Co., Ltd. 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。

K251407電動手持式工具及控制單元（SDI10）K233153Traus SSG10 外科系統 K221741TRAUS空氣牙科手持工具 K212043特拉烏內科醫療設備 FDA、510(k)、PMA、NCT、PMID、識別碼及網址政策：醫療規範-v1 K201292TRAUS SIP20 K192561特拉烏斯 SUS20

查看所有 10 項裝置 →

相關器械（代碼：HBC）

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。

K254174外科電動系統Guizhou Zirui Technology Co., Ltd.K233153Traus SSG10 外科系統Saeshin Precision Co., Ltd.K213697ORiGO 系統Bien-Air Surgery SA K220485無線手控器，EG1A（WIRELESS-HC），無線手控器接收器，EG1A（RECEIVER-HC）The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.K183515MR8 钻孔系統，Midas Rex MR8 清晰視野工具Medtronic Powered Surgical Solutions

官方來源

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