FDA 510(k)

SPRINT 周邊神經刺激（PNS）系統

K 號：K223306 · 2023-01-25

決定日期2023-01-25

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

SPRINT Peripheral Nerve Stimulation (PNS) System is the device name listed in this FDA 510(k) record. The listed applicant is Spr Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K223306. 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 SPRINT Peripheral Nerve Stimulation (PNS) System?

SPRINT Peripheral Nerve Stimulation (PNS) System is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Spr Therapeutics, Inc.. The 510(k) number is K223306.

When did SPRINT Peripheral Nerve Stimulation (PNS) System receive FDA 510(k) clearance?

SPRINT Peripheral Nerve Stimulation (PNS) System received FDA 510(k) clearance on 2023-01-25, under 510(k) number K223306.

Who is the listed applicant for SPRINT Peripheral Nerve Stimulation (PNS) System?

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

What is the FDA product code for SPRINT Peripheral Nerve Stimulation (PNS) System?

The FDA product code for SPRINT Peripheral Nerve Stimulation (PNS) System is NHI.

其他以 Spr Therapeutics, Inc. 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。

K240974SPRINT神經系統系統 K211801SPRINT神經系統系統 K202660SPRINT神經系統系統 K181422SPRINT 周邊神經刺激系統，Extensa，SPRINT 周邊神經刺激系統，Endura，SPRINT 醫學編程套件

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。

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.K202660SPRINT神經系統系統Spr Therapeutics, Inc.

官方來源

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