FDA 510(k)

BD Surgiphor™ 1000 mL 抗菌灌洗系統 (910120)

K 號：K253445 · 2026-02-20

申請人Bd

決定日期2026-02-20

產品代碼FQH

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) is the device name listed in this FDA 510(k) record. The listed applicant is Bd. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K253445. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)?

BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Bd. The 510(k) number is K253445.

When did BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) receive FDA 510(k) clearance?

BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) received FDA 510(k) clearance on 2026-02-20, under 510(k) number K253445.

Who is the listed applicant for BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)?

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

What is the FDA product code for BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)?

The FDA product code for BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) is FQH.

其他以 Bd 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：FQH）

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。

K253996BD Surgiphor™ 抗菌灌洗系統 (910110)Becton, Dickinson and Company (BD)K231023ERBEJET® 2 系統Erbe Elektromedizin GmbH K220759Armis VeriCyn 疤痕清潔Armis Biopharma, Inc.K220964VERSAJET 水刀系統 (III)Smith & Nephew Medical Limited K221504BD Surgiphor™ 抗菌灌洗系統Bd K222804Irrisept 抗菌傷口灌洗器Irrimax Corporation

官方來源

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