FDA 510(k)

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

K号: K232665 · 2024-01-25

决定日期2024-01-25

产品代码EZD

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决定实质等同

器械摘要

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) is the device name listed in this FDA 510(k) record. The listed applicant is Convatec. It received FDA 510(k) clearance on 2024-01-25 under 510(k) number K232665. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)?

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) is a medical device that received FDA 510(k) clearance on 2024-01-25. The listed applicant is Convatec. The 510(k) number is K232665.

When did GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) receive FDA 510(k) clearance?

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) received FDA 510(k) clearance on 2024-01-25, under 510(k) number K232665.

Who is the listed applicant for GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)?

FDA 510(k)记录显示Convatec为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)?

The FDA product code for GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) is EZD.

列明Convatec为申报人的其他记录

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官方来源

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