FDA 510(k)

BD Surgiphor™ 抗菌灌洗系統 (910110)

K 號：K253996 · 2026-02-25

決定日期2026-02-25

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™ Antimicrobial Irrigation System (910110) is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company (BD). It received FDA 510(k) clearance on 2026-02-25 under 510(k) number K253996. 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™ Antimicrobial Irrigation System (910110)?

BD Surgiphor™ Antimicrobial Irrigation System (910110) is a medical device that received FDA 510(k) clearance on 2026-02-25. The listed applicant is Becton, Dickinson and Company (BD). The 510(k) number is K253996.

When did BD Surgiphor™ Antimicrobial Irrigation System (910110) receive FDA 510(k) clearance?

BD Surgiphor™ Antimicrobial Irrigation System (910110) received FDA 510(k) clearance on 2026-02-25, under 510(k) number K253996.

Who is the listed applicant for BD Surgiphor™ Antimicrobial Irrigation System (910110)?

The FDA 510(k) record lists Becton, Dickinson and Company (BD) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Surgiphor™ Antimicrobial Irrigation System (910110)?

The FDA product code for BD Surgiphor™ Antimicrobial Irrigation System (910110) is FQH.

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。

K253445BD Surgiphor™ 1000 mL 抗菌灌洗系統 (910120)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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FQH）

官方來源