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FDA 510(k)

Smartpatch PNS 微型导线及其附件，Smartpatch PNS 刺激器，电极片及其附件，Smartpatch PNS 微型导线和引入器，Smartpatch PNS 电极片，4包装

K号: K161154 · 2016-07-23

申请人Spr Therapeutics, LLC
决定日期2016-07-23
产品代码NHI
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs is the device name listed in this FDA 510(k) record. The listed applicant is Spr Therapeutics, LLC. It received FDA 510(k) clearance on 2016-07-23 under 510(k) number K161154. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs?

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs is a medical device that received FDA 510(k) clearance on 2016-07-23. The listed applicant is Spr Therapeutics, LLC. The 510(k) number is K161154.

When did Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs receive FDA 510(k) clearance?

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs received FDA 510(k) clearance on 2016-07-23, under 510(k) number K161154.

Who is the listed applicant for Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs?

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

What is the FDA product code for Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs?

The FDA product code for Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs is NHI.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Spr Therapeutics, LLC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。

K170902Sprint系统，单次手术套件，Sprint系统带垫II，单次手术套件，Sprint系统，多手术套件，Sprint系统，无菌组件套件，Sprint系统，刺激器套件

相关器械（代码：NHI）

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。

K223306SPRINT 周围神经刺激 (PNS) 系统Spr Therapeutics, Inc.K221425主要缓解Dyansys, Inc.K220397ANSiStim-PPDyansys, Inc.K213188主要缓解Dyansys, Inc.K212859First ReliefDyansys, Inc.K211801SPRINT PNS 系统Spr Therapeutics, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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