FDA 510(k)

Medline ReNewal 再生處理 LigaSure Maryland 齒齒封閉器/分隔器

K 號：K182588 · 2018-10-31

申請人Surgical Instrument Service and Savings Inc.(Dba Medline Ren

決定日期2018-10-31

產品代碼NUJ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider 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 2018-10-31 under 510(k) number K182588. 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 Maryland Jaw Sealer/Divider?

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K182588.

When did Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider receive FDA 510(k) clearance?

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182588.

Who is the listed applicant for Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider?

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 LigaSure Maryland Jaw Sealer/Divider?

The FDA product code for Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is NUJ.

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 K170955Medline ReNewal 再生處理無線超聲刀解剖器 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：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 再生處理 LigaSure Exact Dissector, 細膠膜塗層 (LF2019)Surgical Instrument Service and Savings, Inc.K230251重製LigaSure Curved, 小咬合，開放式封合/分離器 (LF1212A)Stryker Sustainability Solutions K220411重製LigaSure Curved, 小咬合，開放式封合/分離器 (LF1212A)Stryker Sustainability Solutions K211203綠色或再處理Aquamantys雙極封合器Green Or, LLC K191073Vein360 静脈內放射頻率消融 (RFA) 穿刺針Vein 360, LLC K180499再處理LigaSure Maryland咬合封閉器/分離器Stryker Sustainability Solutions

官方來源

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