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FDA 510(k)

Medline ReNewal 再生 Versaport V2 電動無刀片光學 trocars

K 號：K153258 · 2016-04-05

申請人Surgical Instrument Service and Savings (Dba Medline Renewal
決定日期2016-04-05
產品代碼NLM
諮詢委員會GU
決定相當於

器材摘要

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings (Dba Medline Renewal. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K153258. 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 Versaport V2 Bladeless Optical Trocars?

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Surgical Instrument Service and Savings (Dba Medline Renewal. The 510(k) number is K153258.

When did Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars received FDA 510(k) clearance on 2016-04-05, under 510(k) number K153258.

Who is the listed applicant for Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars?

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

What is the FDA product code for Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars?

The FDA product code for Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is NLM.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 SolutionsK182828Medline 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.K160740Medline ReNewal 再生處理 ENDOPATH XCEL Trocar 配備 OPTIVIEW 技術Surgical Instrument Service and Savings, Inc.

官方來源

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