FDA 510(k)

再处理的LigaSure弯曲，小口，开放式密封/分离器（LF1212A）

K号: K230251 · 2023-03-28

决定日期2023-03-28

产品代码NUJ

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决定实质等同

器械摘要

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) 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 2023-03-28 under 510(k) number K230251. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)?

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K230251.

When did Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) receive FDA 510(k) clearance?

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) received FDA 510(k) clearance on 2023-03-28, under 510(k) number K230251.

Who is the listed applicant for Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)?

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 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)?

The FDA product code for Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is NUJ.

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：NUJ）

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。

K232511Medline ReNewal Reprocessed LigaSure 精确分离器，纳米涂层（LF2019）Surgical Instrument Service and Savings, Inc.K220411再处理的LigaSure弯曲，小口，开放式密封/分离器（LF1212A）Stryker Sustainability Solutions K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC K191073Vein360 静脉射频消融（RFA）导管Vein 360, LLC K182588Medline ReNewal Reprocessed LigaSure 马里兰州颚式密封/分隔器Surgical Instrument Service and Savings Inc.(Dba Medline Ren K180499重新处理过的LigaSure Maryland口密封器/分割器Stryker Sustainability Solutions

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。