FDA 510(k)

BD Surgiphor™ 1000 mL 抗菌冲洗系统 (910120)

K号: K253445 · 2026-02-20

申请人Bd

决定日期2026-02-20

产品代码FQH

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Bd为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240257Denali™ 下腔静脉滤过系统 – 髂股部和颈静脉/锁骨下输送套件 K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit K221504BD Surgiphor™ 抗菌冲洗系统 K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。