Cleared Traditional

K930606 - PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (FDA 510(k) Clearance)

Class I Neurology device.

K930606 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Sep 1993
Decision
217d
Days
Class 1
Risk

K930606 is an FDA 510(k) clearance for the PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER. Classified as Instrument, Shunt System Implantation (product code GYK), Class I - General Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Goleta, US). The FDA issued a Cleared decision on September 10, 1993 after a review of 217 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4545 - 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 Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K930606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1993
Decision Date September 10, 1993
Days to Decision 217 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
69d slower than avg
Panel avg: 148d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GYK Instrument, Shunt System Implantation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4545
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.