Cleared Traditional

K023868 - DAN KERRISON RONGEURS, MODELS K1 + BILLY 1

K023868 is an FDA 510(k) clearance for DAN KERRISON RONGEURS, manufactured by Dannoritzer Medical Instruments. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K023868 · Dannoritzer Medical Instruments · Neurology device
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Feb 2003
Decision
79d
Days
Class 2
Risk

K023868 is an FDA 510(k) clearance for the DAN KERRISON RONGEURS, MODELS K1 + BILLY 1. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Dannoritzer Medical Instruments (Hot Springs, US). The FDA issued a Cleared decision on February 7, 2003 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - 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.

FDA 510(k) Submission Details - K023868

510(k) Number K023868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date February 07, 2003
Days to Decision 79 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
70d faster than avg
Panel avg: 149d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAE Device Classification - Class 2, Special Controls

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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 - HAE Rongeur, Manual

All 36
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K023868.
BAXANO ULTRA LOW PROFILE RONGEUR
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MICROBLADE SHAVER AND ACCESSORIES
K063231 · Baxano, Inc. · Apr 2007
ULTRA LOW PROFILE RONGEUR
K062711 · Baxano, Inc. · Mar 2007
BRAY RONGEUR
K954699 · Johnson & Johnson Professionals, Inc. · Dec 1995
KERRISON RONGEURS
K943583 · Enterprise Medical Corp. · Feb 1995
ULTRA-LINE RONGEUR
K943635 · V. Mueller Neuro/Spine · Dec 1994
K023868 · DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
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