NEUSPERA MEDICAL, INC.

FDA Device Registration & Listing · San Jose, CA, US · Registration 3014845032

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014845032
FEI Number
3014845032
Entity Name
NEUSPERA MEDICAL, INC.
City/State/Country
San Jose, CA, US
Establishment Address
51 Daggett Dr, San Jose, CA 95134, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Neuspera Medical, Inc. (Owner Number: 10093664)
Owner / Operator Contact Address
51 Daggett Drive, San Jose, CA 95134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P240031

All Registered Proprietary Names

Neuspera Sacral Neuromodulation (SNM) System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology Class 3 876.5270 2025-06-18

Official Correspondent

Karen Lee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neuspera Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0037-2008 Medtronic Neuromodulation 3
Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.
Z-0040-2008 Medtronic Neuromodulation 3
Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014845032. Last updated year: 2026. Please use registration number 3014845032 when referencing this establishment in official correspondence.
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