Cleared Traditional

K983758 - YASARGIL TITANIUM ANEURYSM CLIPS

K983758 is an FDA 510(k) clearance for YASARGIL TITANIUM ANEURYSM CLIPS, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K983758 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
53d
Days
Class 2
Risk

K983758 is an FDA 510(k) clearance for the YASARGIL TITANIUM ANEURYSM CLIPS. 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 December 18, 1998 after a review of 53 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K983758

510(k) Number K983758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1998
Decision Date December 18, 1998
Days to Decision 53 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
95d faster than avg
Panel avg: 148d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCH Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K983758.
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871 · Aesculap, Inc. · Oct 2000
PSI TITANIUM ANEURYSM CLIP
K991959 · V. Mueller Neuro/Spine · Jan 2000
SUGITA TITANIUM ANEURYSM CLIP
K990202 · Mizuho America, Inc. · Jun 1999
TAKA ANEURYSM CLIP
K972750 · V. Mueller Neuro/Spine · Jul 1998
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050 · Aesculap, Inc. · Nov 1997
SUGITA AVM MICROCLIP
K960037 · Mizuho America, Inc. · Feb 1997