FDA 510(k)

DENSITY; DENZA; DENSITY 黑色

K号: K250065 · 2025-07-08

决定日期2025-07-08

产品代码GEI

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决定实质等同

器械摘要

DENSITY; DENZA; DENSITY Noir is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2025-07-08 under 510(k) number K250065. 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 DENSITY; DENZA; DENSITY Noir?

DENSITY; DENZA; DENSITY Noir is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is Jeisys Medical Incorporated. The 510(k) number is K250065.

When did DENSITY; DENZA; DENSITY Noir receive FDA 510(k) clearance?

DENSITY; DENZA; DENSITY Noir received FDA 510(k) clearance on 2025-07-08, under 510(k) number K250065.

Who is the listed applicant for DENSITY; DENZA; DENSITY Noir?

FDA 510(k)记录显示Jeisys Medical Incorporated为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for DENSITY; DENZA; DENSITY Noir?

The FDA product code for DENSITY; DENZA; DENSITY Noir is GEI.

列明Jeisys Medical Incorporated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。

K254185Potenza Prime K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG 激光单元)K192545Potenza

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.

官方来源

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