FDA 510(k)

Medline ReNewal Reprocessed Harmonic ACE+7 Shears

K号: K193563 · 2020-08-19

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

决定日期2020-08-19

产品代码NLQ

决定实质等同

器械摘要

Medline ReNewal Reprocessed Harmonic ACE+7 Shears 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 2020-08-19 under 510(k) number K193563. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline ReNewal Reprocessed Harmonic ACE+7 Shears?

Medline ReNewal Reprocessed Harmonic ACE+7 Shears is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K193563.

When did Medline ReNewal Reprocessed Harmonic ACE+7 Shears receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Harmonic ACE+7 Shears received FDA 510(k) clearance on 2020-08-19, under 510(k) number K193563.

Who is the listed applicant for Medline ReNewal Reprocessed Harmonic ACE+7 Shears?

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 Harmonic ACE+7 Shears?

The FDA product code for Medline ReNewal Reprocessed Harmonic ACE+7 Shears is NLQ.

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）K182588Medline ReNewal Reprocessed LigaSure 马里兰州颚式密封/分隔器 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：NLQ）

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。

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）Stryker Sustainability Solutions 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）Stryker Sustainability Solutions 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）Stryker Sustainability Solutions K202554再处理的HARMONIC ACE+ 7，5 mm直径剪，具有高级止血功能Stryker Sustainability Solutions K190610再处理的HARMONIC FOCUS剪 + 自适应组织技术Sterilmed, Inc.K182272再处理的HARMONIC ACE+ 7剪，具有高级止血功能Sterilmed, Inc.

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