FDA 510(k)

重製LigaSure Curved, 小咬合，開放式封合/分離器 (LF1212A)

K 號：K220411 · 2022-05-13

決定日期2022-05-13

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 Curved, Small Jaw, Open Sealer/Divider (LF1212A) 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 2022-05-13 under 510(k) number K220411. 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 Curved, Small Jaw, Open Sealer/Divider (LF1212A)?

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K220411.

When did Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) receive FDA 510(k) clearance?

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) received FDA 510(k) clearance on 2022-05-13, under 510(k) number K220411.

Who is the listed applicant for Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)?

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 Curved, Small Jaw, Open Sealer/Divider (LF1212A)?

The FDA product code for Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) 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。

K260636再製LigaSure XP Maryland 齒輪式封合器/分隔器，無納米塗層 K250898再製HARMONIC 700剪刀（HAR723/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度23cm）；再製HARMONIC 700剪刀（HAR736/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度36cm）；再製HARMONIC 700剪刀（HAR745/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度45cm）K241758再處理RD SET Adt pulse oximeter sensor (4000)；再處理RD SET Pdt pulse oximeter sensor (4001)；再處理RD SET Inf pulse oximeter sensor (4002)；再處理RD SET Adt pulse oximeter sensor (4003)K241606再處理HARMONIC 1100剪刀，直徑5mm，長度20cm（HAR1120）；再處理HARMONIC 1100剪刀，直徑5mm，長度36cm（HAR1136）K233471再處理HARMONIC 1100剪刀，直徑5mm，長度20cm（HAR1120）；再處理HARMONIC 1100剪刀，直徑5mm，長度36cm（HAR1136）K231621再處理 ViewFlex Xtra ICE 球囊导管 (D087031)

查看所有 25 項裝置 →

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 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 K180499再處理LigaSure Maryland咬合封閉器/分離器Stryker Sustainability Solutions

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。