Cleared Traditional

K970050 - YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)

K970050 is the FDA 510(k) clearance for YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT) by Aesculap, Inc.. It is a Class 2 Neurology device (product code HCH) cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K970050 · Aesculap, Inc. · Neurology device
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Nov 1997
Decision
324d
Days
Class 2
Risk

K970050 is an FDA 510(k) clearance for the YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT). Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on November 26, 1997 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5200 - 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 K970050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1997
Decision Date November 26, 1997
Days to Decision 324 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
176d slower than avg
Panel avg: 148d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCH Clip, Aneurysm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5200
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 - HCH Clip, Aneurysm

All 17
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K970050.
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · Aesculap, Inc. · Jan 2001
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871 · Aesculap, Inc. · Oct 2000
YASARGIL TITANIUM ANEURYSM CLIPS
K983758 · Aesculap, Inc. · Dec 1998
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc. · Mar 1995
YASARGIL ANEURYSM CLIPS
K922272 · Aesculap, Inc. · Sep 1992
YASARGIL ANEURYSM CLIPS, MODIFICATION
K913765 · Aesculap, Inc. · Mar 1992