FDA 510(k)

再處理LigaSure Maryland咬合封閉器/分離器

K 號：K180499 · 2018-04-23

決定日期2018-04-23

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

Reprocessed LigaSure Maryland Jaw Sealer/Divider is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2018-04-23 under 510(k) number K180499. 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 Reprocessed LigaSure Maryland Jaw Sealer/Divider?

Reprocessed LigaSure Maryland Jaw Sealer/Divider is a medical device that received FDA 510(k) clearance on 2018-04-23. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K180499.

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

Reprocessed LigaSure Maryland Jaw Sealer/Divider received FDA 510(k) clearance on 2018-04-23, under 510(k) number K180499.

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

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed LigaSure Maryland Jaw Sealer/Divider?

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

其他以 Stryker Sustainability Solutions 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 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 K182588Medline ReNewal 再生處理 LigaSure Maryland 齒齒封閉器/分隔器Surgical Instrument Service and Savings Inc.(Dba Medline Ren

官方來源

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