Cleared Traditional

K913412 - PS MEDICAL CSF-ACCESS DEVICE (FDA 510(k) Clearance)

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

K913412 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Mar 1993
Decision
608d
Days
Class 2
Risk

K913412 is an FDA 510(k) clearance for the PS MEDICAL CSF-ACCESS DEVICE. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Goleta, US). The FDA issued a Cleared decision on March 30, 1993 after a review of 608 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K913412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1991
Decision Date March 30, 1993
Days to Decision 608 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
460d slower than avg
Panel avg: 148d · This submission: 608d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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.

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All 257
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