Cleared Traditional

K984109 - AESCULAP AXIAL CLIP APPLIER

K984109 is the FDA 510(k) clearance for AESCULAP AXIAL CLIP APPLIER by Aesculap, Inc.. It is a Class 2 Neurology device (product code HCI) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K984109 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
87d
Days
Class 2
Risk

K984109 is an FDA 510(k) clearance for the AESCULAP AXIAL CLIP APPLIER. Classified as Applier, Aneurysm Clip (product code HCI), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 87 days - a notably fast clearance 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: 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 Aesculap, Inc. devices

Submission Details

510(k) Number K984109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date February 12, 1999
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
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 K984109.
Aesculap Slim Clip Applier
K211572 · Aesculap, Inc. · Dec 2021
Aesculap Slim Clip Applier
K180914 · Aesculap, Inc. · Apr 2018
Aesculap Slim Clip Applier Forceps
K173271 · Aesculap, Inc. · Nov 2017
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