FDA 510(k)

Bovie J-Plasma精确开放式手柄 & Bovie Ultimate Gen 2高频电外科发生器

K号: K170188 · 2017-03-08

决定日期2017-03-08

产品代码GEI

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决定实质等同

器械摘要

Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K170188. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator?

Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Bovie Medical Corporation. The 510(k) number is K170188.

When did Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator receive FDA 510(k) clearance?

Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator received FDA 510(k) clearance on 2017-03-08, under 510(k) number K170188.

Who is the listed applicant for Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator?

The FDA 510(k) record lists Bovie Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator?

The FDA product code for Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator is GEI.

列明Bovie Medical Corporation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。

K183610Renuvion/J-Plasma 精确手持器，Renuvion/J-Plasma 精确开放式手持器，Renuvion/J-Plasma 精确开放式手持器 K170777Bovie J-Plasma精确FLEX手柄 K161558Bovie 3.3mm一次性双极消融器90°，吸痰和非吸痰，Bovie 2.4mm一次性双极消融器55°，非吸痰，Bovie 1.8mm一次性双极消融器60°，非吸痰 K161134Bovie Bantam/PRO电外科发生器，Bovie DERM 941电外科发生器，Bovie DERM 942电外科发生器 K152777Bovie一次性双极消融器

相关器械（代码：GEI）

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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

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