Cleared Special

K013215 - MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013215 · Nuvasive, Inc. · Anesthesiology device
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Oct 2001
Decision
20d
Days
Class 2
Risk

K013215 is an FDA 510(k) clearance for the MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM. Classified as Stimulator, Nerve, Ac-powered (product code BXM), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on October 16, 2001 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nuvasive, Inc. devices

Submission Details

510(k) Number K013215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2001
Decision Date October 16, 2001
Days to Decision 20 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 139d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BXM Stimulator, Nerve, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 Anesthesiology devices follow this clearance model.