Cleared Traditional

K013136 - ANEURYSM CLIPS

K013136 is an FDA 510(k) clearance for ANEURYSM CLIPS, manufactured by Gistlstrasse. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K013136 · Gistlstrasse · Neurology device
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Nov 2001
Decision
68d
Days
Class 2
Risk

K013136 is an FDA 510(k) clearance for the ANEURYSM CLIPS. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Gistlstrasse (Pullach, DE). The FDA issued a Cleared decision on November 26, 2001 after a review of 68 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 Gistlstrasse devices

FDA 510(k) Submission Details - K013136

510(k) Number K013136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2001
Decision Date November 26, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 148d · This submission: 68d
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 29
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K013136.
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · Aesculap, Inc. · Aug 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468 · Cardinalhealth · Jun 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · Aesculap, Inc. · Mar 2003
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
K010908 · Medicon EG · Aug 2001
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · Aesculap, Inc. · Jan 2001
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871 · Aesculap, Inc. · Oct 2000