Cleared Traditional

K231580 - NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231580 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
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Aug 2023
Decision
91d
Days
Class 2
Risk

K231580 is an FDA 510(k) clearance for the NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35). Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 30, 2023 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Xomed, Inc. devices

Submission Details

510(k) Number K231580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2023
Decision Date August 30, 2023
Days to Decision 91 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 89d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K231580.
Evala Nerve Stimulator (EPNR002)
K253536 · Epineuron Technologies, Inc. · Feb 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672 · Medtronic Xomed, Inc. · Feb 2026
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
K242852 · Inomed Medizintechnik GmbH · Jun 2025
Bioscope Neuromonitor Device
K233001 · Biosys Biyomedikal Muhendislik San. VE Tic. A.S. · Dec 2024
EARP Nerve Cuff Electrode
K241917 · Retropsoas Technologies, LLC · Jul 2024
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · Medtronic Xomed, Inc. · Oct 2023