FDA 510(k)

PhotonBlade 3；PhotonBlade 3烟雾排放

K号: K250483 · 2025-09-09

决定日期2025-09-09

产品代码GEI

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决定实质等同

器械摘要

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K250483. 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 PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Stryker Instruments. The 510(k) number is K250483.

When did PhotonBlade 3; PhotonBlade 3 Smoke Evacuation receive FDA 510(k) clearance?

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation received FDA 510(k) clearance on 2025-09-09, under 510(k) number K250483.

Who is the listed applicant for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?

FDA 510(k)记录中列出Stryker Instruments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 PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?

The FDA product code for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is GEI.

列明Stryker Instruments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。

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）K261544Hydro 灌洗系统 K253679Hydro 灌洗系统 K252282SurgiCount+ System K251971RPS 主要全膝关节置换软件；RPS 控制台；RPS Saw One；RPS 电缆；RPS Saw 振动尖端卡式；RPS 控制台车附件；球头指针 K250213OptaBlate BVN 骨内神经消融系统（10mm探头单套件）；OptaBlate BVN 骨内神经消融系统（10mm探头双套件）

查看所有 21 个设备 →

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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