FDA 510(k)

SOLTIVE Pro超脉冲激光，SOLTIVE Premium超脉冲激光，SOLTIVE超脉冲激光光纤和附件

K号: K221306 · 2023-01-27

决定日期2023-01-27

产品代码GEX

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决定实质等同

器械摘要

SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K221306. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories?

SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K221306.

When did SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories receive FDA 510(k) clearance?

SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories received FDA 510(k) clearance on 2023-01-27, under 510(k) number K221306.

Who is the listed applicant for SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories?

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

What is the FDA product code for SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories?

The FDA product code for SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories is GEX. This falls under the Gastroenterology category.

列明Gyrus Acmi, 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。

K252487POWERSEAL 开放扩展嘴封口器和分隔器，双动作（PS-0021EJDA）K233275RenaFlex 单次使用柔性输尿管镜（SUURF-V 标准型）；RenaFlex 单次使用柔性输尿管镜（SUURF-VR 反向型）；单次使用内窥镜视频系统中心（CV-S1）K231327POWERSEAL 封口器和分隔器 K212650Celeris, 一次性窦道清创器 K213831Olympus PK 电外科器械，PK J钩，PK 刮刀，PK 针 K211401SOLTIVE激光系统（SOLTIVE Pro超脉冲激光，SOLTIVE Premium超脉冲激光，SOLTIVE激光光纤和附件）

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官方来源

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