Cleared Traditional

K922272 - YASARGIL ANEURYSM CLIPS

K922272 is the FDA 510(k) clearance for YASARGIL ANEURYSM CLIPS by Aesculap, Inc.. It is a Class 2 Neurology device (product code HCH) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K922272 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
124d
Days
Class 2
Risk

K922272 is an FDA 510(k) clearance for the YASARGIL 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 September 15, 1992 after a review of 124 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K922272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1992
Decision Date September 15, 1992
Days to Decision 124 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 148d · This submission: 124d
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 K922272.
YASARGIL TITANIUM ANEURYSM CLIPS
K983758 · Aesculap, Inc. · Dec 1998
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050 · Aesculap, Inc. · Nov 1997
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc. · Mar 1995
YASARGIL ANEURYSM CLIPS, MODIFICATION
K913765 · Aesculap, Inc. · Mar 1992
HEIFETZ INTRACRANIAL ANEURYSM CLIPS
K832795 · Edward Weck, Inc. · Nov 1983
SCOVILLE-LEWIS ANEURYSM CLIPS
K791764 · Codman & Shurtleff, Inc. · Oct 1979