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FDA 510(k)

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

K 號：K160333 · 2016-07-20

申請人Surgical Instrument Service and Savings, Inc.
決定日期2016-07-20
產品代碼NUJ
諮詢委員會SU
決定Substantially Equivalent

器材摘要

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider 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 2016-07-20 under 510(k) number K160333. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider?

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K160333.

When did Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider receive FDA 510(k) clearance?

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider received FDA 510(k) clearance on 2016-07-20, under 510(k) number K160333.

Who is the listed applicant for Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider?

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 LigaSure Blunt Tip Open Sealer/Divider?

The FDA product code for Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider is NUJ.

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。

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其他以 Surgical Instrument Service and Savings, Inc. 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。

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相關器械（代碼：NUJ）

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。

K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLCK191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLCK182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren

官方來源

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