FDA 510(k)

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）

K号: K233471 · 2024-02-20

决定日期2024-02-20

产品代码NLQ

决定实质等同

器械摘要

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) 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 2024-02-20 under 510(k) number K233471. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

常见问题

What is the Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)?

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) is a medical device that received FDA 510(k) clearance on 2024-02-20. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K233471.

When did Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) receive FDA 510(k) clearance?

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) received FDA 510(k) clearance on 2024-02-20, under 510(k) number K233471.

Who is the listed applicant for Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)?

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 HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)?

The FDA product code for Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) is NLQ.

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）K231621再处理ViewFlex Xtra ICE导管（D087031）K230255翻新 LigaSure Exact 分离器无纳米涂层 LF2019

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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。

官方来源

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