Cleared Traditional

K982379 - SUNDT SLIM-LINE ANEURYSM CLIP APPLIER

K982379 is the FDA 510(k) clearance for SUNDT SLIM-LINE ANEURYSM CLIP APPLIER by Johnson & Johnson Professionals, Inc.. It is a Class 2 Neurology device (product code HCI) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K982379 · Johnson & Johnson Professionals, Inc. · Neurology device
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Dec 1998
Decision
163d
Days
Class 2
Risk

K982379 is an FDA 510(k) clearance for the SUNDT SLIM-LINE ANEURYSM CLIP APPLIER. Classified as Applier, Aneurysm Clip (product code HCI), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 163 days - an extended review cycle.

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. 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K982379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1998
Decision Date December 18, 1998
Days to Decision 163 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
15d slower than avg
Panel avg: 148d · This submission: 163d
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 9
Devices cleared under the same product code (HCI) and FDA review panel - the closest regulatory comparables to K982379.
Aesculap Slim Clip Applier
K180914 · Aesculap, Inc. · Apr 2018
Aesculap Slim Clip Applier Forceps
K173271 · Aesculap, Inc. · Nov 2017
AESCULAP AXIAL CLIP APPLIER
K984109 · Aesculap, Inc. · Feb 1999
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