Cleared Traditional

K833522 - NEURO SECTOR FIXATION DEVICE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833522 · Advanced Technology Laboratories, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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.