FDA 510(k)

TroCare TroKit 腹腔镜镜头擦拭器（CP000626）

K号: K241796 · 2024-10-04

决定日期2024-10-04

产品代码GCJ

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决定实质等同

器械摘要

TroCare TroKit Laparoscope Lens Wiper (CP000626) is the device name listed in this FDA 510(k) record. The listed applicant is TroCare, LLC. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241796. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TroCare TroKit Laparoscope Lens Wiper (CP000626)?

TroCare TroKit Laparoscope Lens Wiper (CP000626) is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is TroCare, LLC. The 510(k) number is K241796.

When did TroCare TroKit Laparoscope Lens Wiper (CP000626) receive FDA 510(k) clearance?

TroCare TroKit Laparoscope Lens Wiper (CP000626) received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241796.

Who is the listed applicant for TroCare TroKit Laparoscope Lens Wiper (CP000626)?

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

What is the FDA product code for TroCare TroKit Laparoscope Lens Wiper (CP000626)?

The FDA product code for TroCare TroKit Laparoscope Lens Wiper (CP000626) is GCJ.

列明TroCare, 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。

K253994TroKit 腹腔镜镜头擦拭器

相关器械（代码：GCJ）

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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官方来源

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