Cleared Traditional

K990793 - ACCUGUIDE MUSCLE INJECTION MONITOR

K990793 is the FDA 510(k) clearance for ACCUGUIDE MUSCLE INJECTION MONITOR by Medtronic Xomed. It is a Class 2 Neurology device (product code GXZ) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K990793 · Medtronic Xomed · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
226d
Days
Class 2
Risk

K990793 is an FDA 510(k) clearance for the ACCUGUIDE MUSCLE INJECTION MONITOR. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on October 22, 1999 after a review of 226 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Xomed devices

Submission Details

510(k) Number K990793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1999
Decision Date October 22, 1999
Days to Decision 226 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 148d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 Neurology devices follow this clearance model.

Regulatory Peers - GXZ Electrode, Needle

All 15
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K990793.
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd. · Aug 2005
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · Cadwell Laboratories, Inc. · Apr 1994
MONOPOLAR EMG NEEDLE ELECTRODE
K933806 · Cadwell Laboratories, Inc. · Apr 1994