Cleared Traditional

PERNECZKY CLIP APPLIER/REMOVER (K954658) - FDA 510(k) Clearance

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

K954658 · Von Zeppelin GmbH · Neurology device
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Oct 1996
Decision
364d
Days
Class 2
Risk

K954658 is an FDA 510(k) clearance for the PERNECZKY CLIP APPLIER/REMOVER. Classified as Applier, Aneurysm Clip (product code HCI), Class II - Special Controls.

Submitted by Von Zeppelin GmbH (Pullach, DE). The FDA issued a Cleared decision on October 8, 1996 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4175 - 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. Elevated predicate reliance profile. 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 Von Zeppelin GmbH devices

Submission Details

510(k) Number K954658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date October 08, 1996
Days to Decision 364 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 148d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCI Applier, Aneurysm Clip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4175
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 - HCI Applier, Aneurysm Clip

All 13
Devices cleared under the same product code (HCI) and FDA review panel - the closest regulatory comparables to K954658.
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K984109 · Aesculap, Inc. · Feb 1999
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · Johnson & Johnson Professionals, Inc. · Dec 1998