Cleared Traditional

K912456 - SUNDT SLIM-LINE GRAFT CLIPS

K912456 is the FDA 510(k) clearance for SUNDT SLIM-LINE GRAFT CLIPS by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HCH) cleared through the Traditional 510(k) pathway after a 1376-day FDA review.

K912456 · Codman & Shurtleff, Inc. · Neurology device
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Mar 1995
Decision
1376d
Days
Class 2
Risk

K912456 is an FDA 510(k) clearance for the SUNDT SLIM-LINE GRAFT CLIPS. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 1376 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K912456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date March 10, 1995
Days to Decision 1376 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
1228d slower than avg
Panel avg: 148d · This submission: 1376d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K912456.
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
YASARGIL ANEURYSM CLIPS
K922272 · Aesculap, Inc. · Sep 1992
YASARGIL ANEURYSM CLIPS, MODIFICATION
K913765 · Aesculap, Inc. · Mar 1992
HEIFETZ INTRACRANIAL ANEURYSM CLIPS
K832795 · Edward Weck, Inc. · Nov 1983