Cleared Traditional

K990793 - ACCUGUIDE MUSCLE INJECTION MONITOR

K990793 is an FDA 510(k) clearance for ACCUGUIDE MUSCLE INJECTION MONITOR, manufactured by Medtronic Xomed. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K990793

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
Combination Product No
PCCP Authorized No
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.

GXZ Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K990793.
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
K050194 · Axon Systems, Inc. · Apr 2005
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · Rhythmlink International, LLC · Dec 2002
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100 · Te ME NA S.A.R.L. · Aug 2000
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597 · Medicotest, Inc. · Jan 1999
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K974119 · Jack'S Electrodes · Jan 1998
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
K950314 · Dantec Medical, Inc. · Mar 1996