Cleared Traditional

K954658 - PERNECZKY CLIP APPLIER/REMOVER

K954658 is an FDA 510(k) clearance for PERNECZKY CLIP APPLIER/REMOVER, manufactured by Von Zeppelin GmbH. The device is a Class 2 Neurology device with product code HCI cleared through the Traditional 510(k) pathway after a 364-day FDA review.

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

FDA 510(k) Submission Details - K954658

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
Combination Product No
PCCP Authorized No
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.

HCI Device Classification - Class 2, Special Controls

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.
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
K994191 · Nmt Medical, Inc. · Feb 2000
AESCULAP AXIAL CLIP APPLIER
K984109 · Aesculap, Inc. · Feb 1999
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · Johnson & Johnson Professionals, Inc. · Dec 1998
YASARGIL, CASPAR, VARIO CLIP APPLIERS
K940970 · Aesculap, Inc. · Jan 1995
SUNDT AVM MICRO CLIP
K902544 · Codman & Shurtleff, Inc. · Sep 1990
NEW SIZES SUGITA CLIPS
K881911 · Downs Surgical , Ltd. · Jun 1988