FDA 510(k)

再处理的HARMONIC FOCUS剪 + 自适应组织技术

K号: K190610 · 2019-08-15

决定日期2019-08-15

产品代码NLQ

决定实质等同

器械摘要

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K190610. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

常见问题

What is the Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Sterilmed, Inc.. The 510(k) number is K190610.

When did Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology receive FDA 510(k) clearance?

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology received FDA 510(k) clearance on 2019-08-15, under 510(k) number K190610.

Who is the listed applicant for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

The FDA product code for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is NLQ.

列明Sterilmed, 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。

K254149再生AcuNav CRYSTAL™超声导管9F x 90 CM，适用于西门子系统（R11510825）；再生AcuNav CRYSTAL™超声导管9F x 90 CM，适用于GE系统（R11657484）；再生SOUNDSTAR CRYSTAL™超声导管9F x 90 CM，适用于西门子系统（R11510826）；再生SOUNDSTAR CRYSTAL™超声导管9F x 90 CM，适用于GE系统（R11657485）K240826再生处理DECANAV™电生理导管；再生处理WEBSTER®双极电生理导管 K190478再处理ViewFlex™ Xtra ICE导管 K182272再处理的HARMONIC ACE+ 7剪，具有高级止血功能 K161700SoundStar eco 8F 3D 诊断 eco 超声波导管，SoundStar eco 8F G 3D 诊断 eco 超声波导管 K161086再处理的Harmonic剪，自适应组织技术（36 cm），再处理的Harmonic剪，自适应组织技术（23cm）

查看所有 10 个设备 →

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 K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren K182272再处理的HARMONIC ACE+ 7剪，具有高级止血功能Sterilmed, Inc.

官方来源

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