FDA 510(k)

Recon Steerable Sheath

K号: K221302 · 2022-08-15

决定日期2022-08-15

产品代码EOQ

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决定实质等同

器械摘要

Recon Steerable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Serpex Medical, Inc.. It received FDA 510(k) clearance on 2022-08-15 under 510(k) number K221302. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Recon Steerable Sheath?

Recon Steerable Sheath is a medical device that received FDA 510(k) clearance on 2022-08-15. The listed applicant is Serpex Medical, Inc.. The 510(k) number is K221302.

When did Recon Steerable Sheath receive FDA 510(k) clearance?

Recon Steerable Sheath received FDA 510(k) clearance on 2022-08-15, under 510(k) number K221302.

Who is the listed applicant for Recon Steerable Sheath?

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

What is the FDA product code for Recon Steerable Sheath?

The FDA product code for Recon Steerable Sheath is EOQ.

列明Serpex Medical, Inc.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。

K252874Compass可调针，配备适配器SRA-1-01和SRA-2-01 K221206Compass可调针

相关器械（代码：EOQ）

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。

K261637一次性使用柔性支气管镜Hunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2；Ambu® aScope™ 5 Broncho 4.2/2.2；Ambu® aScope™ 5 Broncho 4.2/2.2 样本套装Ambu A/S K2540263.8mm 精薄型 ProVu 视频支气管镜（090-02-0038U）；5.0mm 标准型 ProVu 视频支气管镜（090-02-0050U）；6.0mm 大型 ProVu 视频支气管镜（090-02-0060U）；ProVu 视频支气管镜 8 显示器（040-07-0082U）Flexicare Medical Limited.K260382MONARCH™ 平台（MON-000008）Auris Health, Inc.K254037LungFlow气道导管Free Flow Medical, Inc.K253137富士胶片内窥镜型号EB-840S; 富士胶片内窥镜型号EB-840TFujifilm Corporation

官方来源

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