Cleared Traditional

K844352 - SUNDT-KEES REINFORCING ANEURYSM CLIP

K844352 is the FDA 510(k) clearance for SUNDT-KEES REINFORCING ANEURYSM CLIP by Kees Surgical Specialty Co., Inc.. It is a Class 2 Neurology device (product code HCH) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K844352 · Kees Surgical Specialty Co., Inc. · Neurology device
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Jan 1985
Decision
76d
Days
Class 2
Risk

K844352 is an FDA 510(k) clearance for the SUNDT-KEES REINFORCING ANEURYSM CLIP. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Kees Surgical Specialty Co., Inc. (Wilder, US). The FDA issued a Cleared decision on January 24, 1985 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kees Surgical Specialty Co., Inc. devices

Submission Details

510(k) Number K844352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date January 24, 1985
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 148d · This submission: 76d
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 19
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K844352.
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc. · Mar 1995
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
SCOVILLE-LEWIS ANEURYSM CLIPS
K791764 · Codman & Shurtleff, Inc. · Oct 1979
HEIFETZ ANEURYSM CLIP, LMM BLADE
K790413 · Edward Weck, Inc. · Mar 1979