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FDA 510(k)

Medline ReNewal 再生處理無線超聲刀解剖器

K 號：K170955 · 2017-07-03

申請人Surgical Instrument Service and Savings Inc.(Dba Medline Ren
決定日期2017-07-03
產品代碼NLQ
決定相當於

器材摘要

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2017-07-03 under 510(k) number K170955. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector is a medical device that received FDA 510(k) clearance on 2017-07-03. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K170955.

When did Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector received FDA 510(k) clearance on 2017-07-03, under 510(k) number K170955.

Who is the listed applicant for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

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

What is the FDA product code for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

The FDA product code for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector is NLQ.

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

其他以 Surgical Instrument Service and Savings Inc.(Dba Medline Ren 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。

K241224美林ReNewal再加工Biosense Webster Webster CS心导管，配EZ Steer技術及美林ReNewal再加工Biosense Webster Webster CS心导管，配EZ Steer技術及自動識別技術（BD710DF282CT，BD710DF282RTS，BD710FJ282RTS，BD710FJ282CT）K193563Medline ReNewal 再生調和 ACE+7 剪刀K182588Medline ReNewal 再生處理 LigaSure Maryland 齒齒封閉器/分隔器K153745Medline ReNewal 再生處理 LigaSure Impact 開放式封合/分離器K151617Livewire 電生理學導管

相關器械（代碼：NLQ）

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。

K250898再製HARMONIC 700剪刀（HAR723/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度23cm）；再製HARMONIC 700剪刀（HAR736/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度36cm）；再製HARMONIC 700剪刀（HAR745/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度45cm）Stryker Sustainability SolutionsK241606再處理HARMONIC 1100剪刀，直徑5mm，長度20cm（HAR1120）；再處理HARMONIC 1100剪刀，直徑5mm，長度36cm（HAR1136）Stryker Sustainability SolutionsK233471再處理HARMONIC 1100剪刀，直徑5mm，長度20cm（HAR1120）；再處理HARMONIC 1100剪刀，直徑5mm，長度36cm（HAR1136）Stryker Sustainability SolutionsK202554再處理 HARMONIC ACE+ 7, 5 毫米直徑剪刀，具有先進止血功能Stryker Sustainability SolutionsK193563Medline ReNewal 再生調和 ACE+7 剪刀Surgical Instrument Service and Savings Inc.(Dba Medline RenK190610再處理 HARMONIC FOCUS 剪 + 自適應組織技術Sterilmed, Inc.

官方來源

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