FDA 510(k)

再製LigaSure Exact Dissector，無納米塗層（LF2019）

K 號：K220481 · 2022-05-25

決定日期2022-05-25

產品代碼GEI

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

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) 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 2022-05-25 under 510(k) number K220481. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K220481.

When did Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) receive FDA 510(k) clearance?

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220481.

Who is the listed applicant for Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

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 Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

The FDA product code for Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) is GEI.

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：GEI）

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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官方來源

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