Cleared Traditional

K833522 - NEURO SECTOR FIXATION DEVICE

K833522 is the FDA 510(k) clearance for NEURO SECTOR FIXATION DEVICE by Advanced Technology Laboratories, Inc.. It is a Class 2 Neurology device (product code GXW) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K833522 · Advanced Technology Laboratories, Inc. · Neurology device
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May 1984
Decision
249d
Days
Class 2
Risk

K833522 is an FDA 510(k) clearance for the NEURO SECTOR FIXATION DEVICE. Classified as Echoencephalograph (product code GXW), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on May 25, 1984 after a review of 249 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1240 - 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 Advanced Technology Laboratories, Inc. devices

Submission Details

510(k) Number K833522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1983
Decision Date May 25, 1984
Days to Decision 249 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 148d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXW Echoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1240
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 - GXW Echoencephalograph

Devices cleared under the same product code (GXW) and FDA review panel - the closest regulatory comparables to K833522.
SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
K921863 · Hewlett-Packard Co. · Sep 1992
SMS-712NA
K903085 · Toshiba America Medical Systems, In.C · Oct 1990
5.0 IOP & 7.5 IOP PROBES
K853432 · Diasonics, Inc. · Feb 1986
ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000
K770788 · Storz Instrument Co. · May 1977
ECHOENCEPHALOGRAPH, DIGITAL, 1000
K770575 · Storz Instrument Co. · Apr 1977