Cleared Traditional

K940970 - YASARGIL

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

K940970 · Aesculap, Inc. · Neurology device
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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

Submission Details

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.

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 K940970.
Aesculap Slim Clip Applier Forceps
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K984109 · Aesculap, Inc. · Feb 1999
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · Johnson & Johnson Professionals, Inc. · Dec 1998
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