Cleared Traditional

K002677 - NUVASIVE INS-1 INTRAOPERATIVE NERVE SUR...

K002677 is an FDA 510(k) clearance for NUVASIVE INS-1 INTRAOPERATIVE NERVE SUR..., manufactured by Nuvasive, Inc.. The device is a Class 2 Anesthesiology device with product code BXM cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K002677 · Nuvasive, Inc. · Anesthesiology device
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Nov 2000
Decision
77d
Days
Class 2
Risk

K002677 is an FDA 510(k) clearance for the NUVASIVE 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 November 13, 2000 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nuvasive, Inc. devices

FDA 510(k) Submission Details - K002677

510(k) Number K002677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2000
Decision Date November 13, 2000
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BXM Device Classification - Class 2, Special Controls

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.