FDA.reportPublic FDA data

Neuspera SNM System

Primary DI
00850075633005
Brand
Neuspera SNM System
Company
NeuSpera Medical Inc.
Model
SNS-28
Device description
Sacral Nerve Stimulator Implant Kit
Published
2025-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZWStimulator, Electrical, Implantable, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240031000Neuspera Sacral Neuromodulation SystemNeuspera Medical, Inc.2025-06-17EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850075633005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075633005008500756330058500756330050850075633005

GMDN Terms#

Term, Definition table
TermDefinition
Implantable incontinence-control electrical stimulation system pulse generatorA sterile, hermetically-sealed, battery-powered component of an implantable incontinence-control pelvic electrical stimulation system, intended to be implanted beneath the skin (e.g., upper buttock area) to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via implantable electrodes (not included), and the pulse generator may be controlled by an external programmer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033985298
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850075633135Neuspera SNM SystemWBTS-S2026-04-29
00850075633425Neuspera SNM SystemWBTS-M2026-04-29
00850075633432Neuspera SNM SystemWBTS-L2026-04-29
00850075633449Neuspera SNM SystemWBTS-XL2026-04-29
00850075633456Neuspera SNM SystemWBT-S2026-04-29
00850075633463Neuspera SNM SystemWBT-M2026-04-29
00850075633470Neuspera SNM SystemWBT-L2026-04-29
00850075633487Neuspera SNM SystemWBT-XL2026-04-29
00850075633036Neuspera SNM SystemWU-L-XS2025-11-17
00850075633142Neuspera SNM SystemWU-L-S2025-11-17
00850075633159Neuspera SNM SystemWU-L-M2025-11-17
00850075633166Neuspera SNM SystemWU-L-L2025-11-17
00850075633173Neuspera SNM SystemWU-L-XL2025-11-17
00850075633180Neuspera SNM SystemWU-L-2XL2025-11-17
00850075633197Neuspera SNM SystemWU-L-3XL2025-11-17
00850075633203Neuspera SNM SystemWU-R-XS2025-11-17
00850075633210Neuspera SNM SystemWU-R-S2025-11-17
00850075633227Neuspera SNM SystemWU-R-M2025-11-17
00850075633234Neuspera SNM SystemWU-R-L2025-11-17
00850075633241Neuspera SNM SystemWU-R-XL2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075633135Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633425Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633432Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633449Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633456Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633463Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633470Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633487Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00199150005918NAMEDTRONIC, INC.EZW2026-03-27
00199150005925NAMEDTRONIC, INC.EZW2026-03-27
00850075633081Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-12-02
00850075633012Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633029Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633036Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633043Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633067Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633098Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633104Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633111Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633128Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633142Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633159Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633166Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633173Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633180Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633197Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633203Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633210Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633227Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633234Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17