Retropsoas Electrode

FDA UDI

Class II (US FDA UDI)

by Nvision Biomedical Technologies, Inc

Identity

Trade Name: Retropsoas Electrode FDA UDI
Generic Name: Nerve-locating system probe, single-use FDA UDI
Device Name: Retropsoas Electrode, NERVE CUFF ELECTRODE, 4MM The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery. FDA UDI
Model / Reference: ELEC1000-04 FDA UDI
Description: Retropsoas Electrode, NERVE CUFF ELECTRODE, 4MM The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810135960502 FDA UDI
510(k) Number: K230853 FDA UDI
FDA Product Code: ETN FDA UDI
GMDN Term: Nerve-locating system probe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 4 Millimeter FDA UDI
Height — 5 Millimeter FDA UDI

Category: Nerve-locating system probe, single-use

Retropsoas Electrode by Nvision Biomedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Nerve-locating system probe, single-use.

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SafeOp 3 — ALPHATEC SPINE, INC. · Class II
IOM Stimulator Probes — SPES MEDICA SPA · Class II
NIM-Spine® — MEDTRONIC SOFAMOR DANEK, INC. · Class II

Cleared under the same submission

K230853 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Nvision Biomedical Technologies, Inc

Sources (1)

FDA UDI 4a115659-2eb8-4d0a-b0d1-bb28553fba2b 36 fields · synced Jun 7, 2026