Cleared Traditional

K033660 - STORZ RANEY SCALP CLIP, MODEL 1-20-004-05

K033660 is an FDA 510(k) clearance for STORZ RANEY SCALP CLIP, manufactured by Rudolf Storz GmbH. The device is a Class 2 Neurology device with product code HBO cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K033660 · Rudolf Storz GmbH · Neurology device
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Jan 2004
Decision
47d
Days
Class 2
Risk

K033660 is an FDA 510(k) clearance for the STORZ RANEY SCALP CLIP, MODEL 1-20-004-05. Classified as Clip, Scalp (product code HBO), Class II - Special Controls.

Submitted by Rudolf Storz GmbH (Amsterdam, NL). The FDA issued a Cleared decision on January 7, 2004 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4150 - 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 Rudolf Storz GmbH devices

FDA 510(k) Submission Details - K033660

510(k) Number K033660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date January 07, 2004
Days to Decision 47 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 148d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBO Device Classification - Class 2, Special Controls

Product Code HBO Clip, Scalp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4150
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 - HBO Clip, Scalp

All 7
Devices cleared under the same product code (HBO) and FDA review panel - the closest regulatory comparables to K033660.
Raney Clips Kit
K253814 · Beijing Honghugaoxiang Science and Technology Development CO · Jul 2026
MEDTRONIC CLIP GUN KIT
K050044 · Medtronic Neurosurgery · Feb 2005
SCALPFIX CLIP SYSTEM
K012219 · Aesculap, Inc. · Jul 2001
CODMAN DISPOSABLE SCALP CLIP APPLIER
K905433 · Codman & Shurtleff, Inc. · Feb 1991
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
K894778 · Codman & Shurtleff, Inc. · Dec 1989
RANEY AND LEROY-RANEY SCALP CLIP
K883963 · New England Surgical Instrument Corp. · Oct 1988