Cleared Traditional

K003500 - REBSTOCK YASARGIL ANEURYSM CLIP

K003500 is an FDA 510(k) clearance for REBSTOCK YASARGIL ANEURYSM CLIP, manufactured by Rebstock - Instrumente GmbH. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K003500 · Rebstock - Instrumente GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
198d
Days
Class 2
Risk

K003500 is an FDA 510(k) clearance for the REBSTOCK YASARGIL ANEURYSM CLIP. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Rebstock - Instrumente GmbH (Duerbheim, DE). The FDA issued a Cleared decision on May 30, 2001 after a review of 198 days - an extended review 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: 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 Rebstock - Instrumente GmbH devices

FDA 510(k) Submission Details - K003500

510(k) Number K003500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2000
Decision Date May 30, 2001
Days to Decision 198 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
50d slower than avg
Panel avg: 148d · This submission: 198d
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 K003500.
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
PSI TITANIUM ANEURYSM CLIP
K991959 · V. Mueller Neuro/Spine · Jan 2000