FDA 510(k)

翻新 LigaSure Exact 分离器，无纳米涂层 (LF2019)

K号: K220481 · 2022-05-25

决定日期2022-05-25

产品代码GEI

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决定实质等同

器械摘要

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220481. 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 Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K220481.

When did Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) receive FDA 510(k) clearance?

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220481.

Who is the listed applicant for Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

The FDA product code for Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) is GEI.

列明Stryker Sustainability Solutions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。

K260636翻新 LigaSure XP Maryland 齿轮封口器/分隔器无纳米涂层 K250898再处理的HARMONIC 700剪（HAR723/再处理的HARMONIC 700，5mm直径剪，高级止血x 23cm）；再处理的HARMONIC 700剪（HAR736/再处理的HARMONIC 700，5mm直径剪，高级止血x 36cm）；再处理的HARMONIC 700剪（HAR745/再处理的HARMONIC 700，5mm直径剪，高级止血x 45cm）K241758重新处理过的RD SET Adt脉搏血氧仪传感器（4000）；重新处理过的RD SET Pdt脉搏血氧仪传感器（4001）；重新处理过的RD SET Inf脉搏血氧仪传感器（4002）；重新处理过的RD SET Adt脉搏血氧仪传感器（4003）K241606再处理的HARMONIC 1100剪，5mm直径，20cm长度（HAR1120）；再处理的HARMONIC 1100剪，5mm直径，36cm长度（HAR1136）K233471再处理的HARMONIC 1100剪，5mm直径，20cm长度（HAR1120）；再处理的HARMONIC 1100剪，5mm直径，36cm长度（HAR1136）K231621再处理ViewFlex Xtra ICE导管（D087031）

查看所有 25 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.

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