FDA 510(k)

Medline ReNewal 再生處理 LigaSure Exact Dissector, 細膠膜塗層 (LF2019)

K 號：K232511 · 2024-04-29

申請人Surgical Instrument Service and Savings, Inc.

決定日期2024-04-29

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 Exact Dissector, Nano-coated (LF2019) 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 2024-04-29 under 510(k) number K232511. 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 Exact Dissector, Nano-coated (LF2019)?

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K232511.

When did Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) receive FDA 510(k) clearance?

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) received FDA 510(k) clearance on 2024-04-29, under 510(k) number K232511.

Who is the listed applicant for Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)?

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 Exact Dissector, Nano-coated (LF2019)?

The FDA product code for Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) is NUJ.

其他以 Surgical Instrument Service and Savings, Inc. 為申請人之記錄

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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。

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官方來源

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