FDA 510(k)

Medline ReNewal Reprocessed LigaSure 马里兰州颚式密封/分隔器

K号: K182588 · 2018-10-31

申请人Surgical Instrument Service and Savings Inc.(Dba Medline Ren

决定日期2018-10-31

产品代码NUJ

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决定实质等同

器械摘要

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K182588. 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 Maryland Jaw Sealer/Divider?

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K182588.

When did Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider receive FDA 510(k) clearance?

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182588.

Who is the listed applicant for Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider?

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

What is the FDA product code for Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider?

The FDA product code for Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is NUJ.

列明Surgical Instrument Service and Savings Inc.(Dba Medline Ren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。

K241224Medline ReNewal Reprocessed Biosense Webster Webster CS 导管带 EZ Steer 技术，以及 Medline ReNewal Reprocessed Biosense Webster Webster CS 导管带带 EZ Steer 技术和自动 ID 技术（BD710DF282CT，BD710DF282RTS，BD710FJ282RTS，BD710FJ282CT）K193563Medline ReNewal Reprocessed Harmonic ACE+7 Shears K170955Medline ReNewal Reprocessed Sonicision 无线超声解剖器 K153745Medline ReNewal Reprocessed LigaSure 影响开放式密封/分隔器 K151617Livewire 电生理导管

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.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 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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