FDA 510(k)

Konig 贝尔环状包皮环切夹

K号: K251687 · 2026-02-25

决定日期2026-02-25

产品代码HFX

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决定实质等同

器械摘要

Konig Bell Circumcision Clamp is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2026-02-25 under 510(k) number K251687. The device is classified under product code HFX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Konig Bell Circumcision Clamp?

Konig Bell Circumcision Clamp is a medical device that received FDA 510(k) clearance on 2026-02-25. The listed applicant is Medline Industries, LP. The 510(k) number is K251687.

When did Konig Bell Circumcision Clamp receive FDA 510(k) clearance?

Konig Bell Circumcision Clamp received FDA 510(k) clearance on 2026-02-25, under 510(k) number K251687.

Who is the listed applicant for Konig Bell Circumcision Clamp?

FDA 510(k)记录显示Medline Industries, LP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 Konig Bell Circumcision Clamp?

The FDA product code for Konig Bell Circumcision Clamp is HFX.

列明Medline Industries, LP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。

K253526NAMIC 扩张器和套管 K254287Medline 可重复使用血压袖带 K253322Hudson RCI® 婴儿Dri-TechTM 呼吸回路（HUD99060 / Dri-Tech 婴儿回路，HUD99060KIT / Dri-Tech 婴儿回路套件，HUD99001KIT / 单肢婴儿回路Dri-Tech 套件，HUD99009KIT / Dri-Tech 婴儿回路套件，HUD99018KIT / Dri-Tech 婴儿回路套件，HUD870NKIT / Dri-Tech 婴儿附件袋，HUD1631 / 婴儿Y型连接器带旋转接头）K253070Namic径向臂带，23厘米（DYNJRADBAND）；Namic径向臂带，26厘米（DYNJRADBANDL）K250345Medline 袋式过滤器 K250312Hudson RCI® Comfort Flo 鼻导管早产儿，婴儿；Hudson RCI® Comfort Flo Plus 和 Soft Plus 鼻导管超小号

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官方来源

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