Cleared Traditional

K972750 - TAKA ANEURYSM CLIP

K972750 is an FDA 510(k) clearance for TAKA ANEURYSM CLIP, manufactured by V. Mueller Neuro/Spine. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K972750 · V. Mueller Neuro/Spine · Neurology device
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Jul 1998
Decision
351d
Days
Class 2
Risk

K972750 is an FDA 510(k) clearance for the TAKA ANEURYSM CLIP. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by V. Mueller Neuro/Spine (San Carlos, US). The FDA issued a Cleared decision on July 9, 1998 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 V. Mueller Neuro/Spine devices

FDA 510(k) Submission Details - K972750

510(k) Number K972750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1997
Decision Date July 09, 1998
Days to Decision 351 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
203d slower than avg
Panel avg: 148d · This submission: 351d
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 24
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K972750.
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · Aesculap, Inc. · Jan 2001
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871 · Aesculap, Inc. · Oct 2000
YASARGIL TITANIUM ANEURYSM CLIPS
K983758 · Aesculap, Inc. · Dec 1998
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050 · Aesculap, Inc. · Nov 1997
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
K960372 · Scanlan Intl., Inc. · Apr 1996
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc. · Mar 1995