Cleared Traditional

K955064 - SPETZLER TI 100 ANEURYSM CLIP

K955064 is an FDA 510(k) clearance for SPETZLER TI 100 ANEURYSM CLIP, manufactured by Elekta Instruments, Inc.. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K955064 · Elekta Instruments, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
346d
Days
Class 2
Risk

K955064 is an FDA 510(k) clearance for the SPETZLER TI 100 ANEURYSM CLIP. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Elekta Instruments, Inc. (Atlanta, US). The FDA issued a Cleared decision on October 17, 1996 after a review of 346 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 Elekta Instruments, Inc. devices

FDA 510(k) Submission Details - K955064

510(k) Number K955064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1995
Decision Date October 17, 1996
Days to Decision 346 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 148d · This submission: 346d
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 28
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K955064.
TAKA ANEURYSM CLIP
K972750 · V. Mueller Neuro/Spine · Jul 1998
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050 · Aesculap, Inc. · Nov 1997
SUGITA AVM MICROCLIP
K960037 · Mizuho America, Inc. · Feb 1997
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
K960372 · Scanlan Intl., Inc. · Apr 1996
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc. · Mar 1995
YASARGIL ANEURYSM CLIPS
K922272 · Aesculap, Inc. · Sep 1992