FDA 510(k)

LIGACLIP内窥镜旋转多夹持器12mm L（ER420）；LIGACLIP内窥镜旋转多夹持器10mm M/L（ER320）

K号: K232313 · 2023-08-29

决定日期2023-08-29

产品代码FZP

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决定实质等同

器械摘要

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo Surgery, LLC. It received FDA 510(k) clearance on 2023-08-29 under 510(k) number K232313. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)?

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) is a medical device that received FDA 510(k) clearance on 2023-08-29. The listed applicant is Ethicon Endo Surgery, LLC. The 510(k) number is K232313.

When did LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) receive FDA 510(k) clearance?

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) received FDA 510(k) clearance on 2023-08-29, under 510(k) number K232313.

Who is the listed applicant for LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)?

The FDA 510(k) record lists Ethicon Endo Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)?

The FDA product code for LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) is FZP.

列明Ethicon Endo Surgery, LLC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。

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