Cleared Traditional

K940970 - YASARGIL, CASPAR, VARIO CLIP APPLIERS

K940970 is an FDA 510(k) clearance for YASARGIL, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HCI cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K940970 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
328d
Days
Class 2
Risk

K940970 is an FDA 510(k) clearance for the YASARGIL, CASPAR, VARIO CLIP APPLIERS. 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 January 24, 1995 after a review of 328 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K940970

510(k) Number K940970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1994
Decision Date January 24, 1995
Days to Decision 328 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
180d slower than avg
Panel avg: 148d · This submission: 328d
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 K940970.
AESCULAP AXIAL CLIP APPLIER
K984109 · Aesculap, Inc. · Feb 1999
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · Johnson & Johnson Professionals, Inc. · Dec 1998
PERNECZKY CLIP APPLIER/REMOVER
K954658 · Von Zeppelin GmbH · Oct 1996
SUNDT AVM MICRO CLIP
K902544 · Codman & Shurtleff, Inc. · Sep 1990
NEW SIZES SUGITA CLIPS
K881911 · Downs Surgical , Ltd. · Jun 1988
SANO CLIP APPLIERS & REMOVERS
K881912 · Downs Surgical , Ltd. · Jun 1988