FDA 510(k)

Medline ReNewal Reprocessed LigaSure 精确分离器，纳米涂层（LF2019）

K号: K232511 · 2024-04-29

申请人Surgical Instrument Service and Savings, Inc.

决定日期2024-04-29

产品代码NUJ

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决定实质等同

器械摘要

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2024-04-29 under 510(k) number K232511. 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 Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)?

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K232511.

When did Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) receive FDA 510(k) clearance?

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) received FDA 510(k) clearance on 2024-04-29, under 510(k) number K232511.

Who is the listed applicant for Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)?

The FDA product code for Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) is NUJ.

列明Surgical Instrument Service and Savings, Inc.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。

K250314Medline ReNewal 复加工 Abbott Agilis Nxt 导入器 K252405Medline ReNewal Reprocessed Boston Scientific 动态尖端单向可调节诊断导管 K250772Medline ReNewal Reprocessed Boston Scientific 动态 XT 单向可调节诊断导管 K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco 诊断超声导管（8F，8FG，10F，10FG）K243101Medline ReNewal Reprocessed 西门子 ACUSON AcuNav 10F 超声波导管（适用于西门子系统）（08255790）；Medline ReNewal Reprocessed 西门子 ACUSON AcuNav 10F 超声波导管（适用于GE系统）（10043342）K242225Medline ReNewal Reprocessed Abbott Inquiry 可调节诊断导管

查看所有 23 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。

K230251再处理的LigaSure弯曲，小口，开放式密封/分离器（LF1212A）Stryker Sustainability Solutions 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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