FDA 510(k)

Saberscope5 腹腔镜

K号: K220872 · 2022-04-20

决定日期2022-04-20

产品代码GCJ

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决定实质等同

器械摘要

Saberscope5 Laparoscope is the device name listed in this FDA 510(k) record. The listed applicant is Xenocor, Inc.. It received FDA 510(k) clearance on 2022-04-20 under 510(k) number K220872. 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 Saberscope5 Laparoscope?

Saberscope5 Laparoscope is a medical device that received FDA 510(k) clearance on 2022-04-20. The listed applicant is Xenocor, Inc.. The 510(k) number is K220872.

When did Saberscope5 Laparoscope receive FDA 510(k) clearance?

Saberscope5 Laparoscope received FDA 510(k) clearance on 2022-04-20, under 510(k) number K220872.

Who is the listed applicant for Saberscope5 Laparoscope?

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

What is the FDA product code for Saberscope5 Laparoscope?

The FDA product code for Saberscope5 Laparoscope is GCJ.

列明Xenocor, 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。

K260177Saberscope® 腹腔镜 (SAS-A-536L)；Xenocor® 视频处理单元 (VPUX-1)K193315Xenocor 关节式 Xenoscope 腹腔镜 K171344Xenocor Xenoscope 腹腔镜系统 K161838Xenocor Xenoscope 腹腔镜系统

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

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