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FDA 510(k)

TSolution One Cup1 Surgical System

K 號：K162195 · 2016-09-14

申請人THINK Surgical, Inc.
決定日期2016-09-14
產品代碼OLO
諮詢委員會NE
決定Substantially Equivalent

器材摘要

TSolution One Cup1 Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is THINK Surgical, Inc.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K162195. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TSolution One Cup1 Surgical System?

TSolution One Cup1 Surgical System is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is THINK Surgical, Inc.. The 510(k) number is K162195.

When did TSolution One Cup1 Surgical System receive FDA 510(k) clearance?

TSolution One Cup1 Surgical System received FDA 510(k) clearance on 2016-09-14, under 510(k) number K162195.

Who is the listed applicant for TSolution One Cup1 Surgical System?

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

What is the FDA product code for TSolution One Cup1 Surgical System?

The FDA product code for TSolution One Cup1 Surgical System is OLO.

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相關器械（代碼：OLO）

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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