Cleared Traditional

K915546 - PS MEDICAL VENTRICULOSTOMY KIT

K915546 is the FDA 510(k) clearance for PS MEDICAL VENTRICULOSTOMY KIT by Pudenz-Schulte Medical Research Corp.. It is a Class 2 Neurology device (product code HBG) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K915546 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Dec 1991
Decision
19d
Days
Class 2
Risk

K915546 is an FDA 510(k) clearance for the PS MEDICAL VENTRICULOSTOMY KIT. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Goleta, US). The FDA issued a Cleared decision on December 30, 1991 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K915546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1991
Decision Date December 30, 1991
Days to Decision 19 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 148d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBG Drills, Burrs, Trephines & Accessories (manual)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4300
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 - HBG Drills, Burrs, Trephines & Accessories (manual)

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