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FDA 510(k)

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）

K 號：K250898 · 2025-08-14

申請人Stryker Sustainability Solutions
決定日期2025-08-14
產品代碼NLQ
決定相當於

器材摘要

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) 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 2025-08-14 under 510(k) number K250898. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)?

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) is a medical device that received FDA 510(k) clearance on 2025-08-14. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K250898.

When did Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) receive FDA 510(k) clearance?

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) received FDA 510(k) clearance on 2025-08-14, under 510(k) number K250898.

Who is the listed applicant for Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)?

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 HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)?

The FDA product code for Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) is NLQ.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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)K230255再製LigaSure Exact Dissector無納米塗層 LF2019

查看所有 25 項裝置 →

相關器械（代碼：NLQ）

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。

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）Stryker Sustainability SolutionsK233471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）Stryker Sustainability SolutionsK202554再處理 HARMONIC ACE+ 7, 5 毫米直徑剪刀，具有先進止血功能Stryker Sustainability SolutionsK193563Medline ReNewal 再生調和 ACE+7 剪刀Surgical Instrument Service and Savings Inc.(Dba Medline RenK190610再處理 HARMONIC FOCUS 剪 + 自適應組織技術Sterilmed, Inc.K182272再處理HARMONIC ACE+ 7剪刀，配備先進止血功能Sterilmed, Inc.

官方來源

在 FDA 資料庫中查看 →

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