FDA 510(k)

Medline ReNewal 再生處理 ENDOPATH XCEL Trocar 配備 OPTIVIEW 技術

K 號：K160740 · 2016-05-06

申請人Surgical Instrument Service and Savings, Inc.

決定日期2016-05-06

產品代碼NLM

諮詢委員會GU

決定相當於

器材摘要

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K160740. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology?

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K160740.

When did Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology receive FDA 510(k) clearance?

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology received FDA 510(k) clearance on 2016-05-06, under 510(k) number K160740.

Who is the listed applicant for Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology?

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

What is the FDA product code for Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology?

The FDA product code for Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is NLM.

其他以 Surgical Instrument Service and Savings, Inc. 為申請人之記錄

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相關器械（代碼：NLM）

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。

K201511再處理內視鏡套管及套筒Stryker Sustainability Solutions K182828Medline ReNewal 再生 Carter-Thomason 尖端針線輸送器Surgical Instrument Service and Savings, Inc.K172097重製伊士曼無刀片 trocars；重製伊士曼通用 trocar 套管Renovo, Inc.K172093重製科維登 TrocarRenovo, Inc.K153258Medline ReNewal 再生 Versaport V2 電動無刀片光學 trocarsSurgical Instrument Service and Savings (Dba Medline Renewal

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