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FDA 510(k)

Smartpatch PNS 微導管及配件、Smartpatch PNS 刺激器、墊片及配件、Smartpatch PNS 微導管及導入器、Smartpatch PNS 墊片，4 套組

K 號：K161154 · 2016-07-23

申請人Spr Therapeutics, LLC
決定日期2016-07-23
產品代碼NHI
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Spr Therapeutics, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K170902Sprint 系統，單一程序套件，Sprint 系統搭配 Pad II，單一程序套件，Sprint 系統，多程序套件，Sprint 系統，无菌组件套件，Sprint 系統，刺激器套件

相關器械（代碼：NHI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K223306SPRINT 周邊神經刺激（PNS）系統Spr Therapeutics, Inc.K221425主要緩解Dyansys, Inc.K220397ANSiStim-PPDyansys, Inc.K213188主要緩解Dyansys, Inc.K212859First ReliefDyansys, Inc.K211801SPRINT神經系統系統Spr Therapeutics, Inc.

官方來源

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