Cleared Traditional

K010910 - MEDICON YASARGIL CLIP APPLYING FORCEPS

K010910 is an FDA 510(k) clearance for MEDICON YASARGIL CLIP APPLYING FORCEPS, manufactured by Medicon EG. The device is a Class 2 Neurology device with product code HCI cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K010910 · Medicon EG · Neurology device
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Aug 2001
Decision
128d
Days
Class 2
Risk

K010910 is an FDA 510(k) clearance for the MEDICON YASARGIL CLIP APPLYING FORCEPS. Classified as Applier, Aneurysm Clip (product code HCI), Class II - Special Controls.

Submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on August 1, 2001 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4175 - 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 Medicon EG devices

FDA 510(k) Submission Details - K010910

510(k) Number K010910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date August 01, 2001
Days to Decision 128 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
20d faster than avg
Panel avg: 148d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCI Device Classification - Class 2, Special Controls

Product Code HCI Applier, Aneurysm Clip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4175
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 - HCI Applier, Aneurysm Clip

All 11
Devices cleared under the same product code (HCI) and FDA review panel - the closest regulatory comparables to K010910.
Aesculap Slim Clip Applier
K211572 · Aesculap, Inc. · Dec 2021
Aesculap Slim Clip Applier
K180914 · Aesculap, Inc. · Apr 2018
Aesculap Slim Clip Applier Forceps
K173271 · Aesculap, Inc. · Nov 2017
AESCULAP AXIAL CLIP APPLIER
K984109 · Aesculap, Inc. · Feb 1999
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · Johnson & Johnson Professionals, Inc. · Dec 1998
YASARGIL, CASPAR, VARIO CLIP APPLIERS
K940970 · Aesculap, Inc. · Jan 1995