Cleared Traditional

K844594 - NEURO CUSTOM SURGICAL KIT

K844594 is an FDA 510(k) clearance for NEURO CUSTOM SURGICAL KIT, manufactured by Xanmed Corp.. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K844594 · Xanmed Corp. · Neurology device
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Jun 1985
Decision
199d
Days
Class 2
Risk

K844594 is an FDA 510(k) clearance for the NEURO CUSTOM SURGICAL KIT. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by Xanmed Corp. (Washington, US). The FDA issued a Cleared decision on June 13, 1985 after a review of 199 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - 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 Xanmed Corp. devices

FDA 510(k) Submission Details - K844594

510(k) Number K844594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1984
Decision Date June 13, 1985
Days to Decision 199 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 148d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBA Device Classification - Class 2, Special Controls

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
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.