Cleared Traditional

K113273 - SPOTLIGHT ACCESS SYSTEM

K113273 is an FDA 510(k) clearance for SPOTLIGHT ACCESS SYSTEM, manufactured by Johnson & Johnson. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K113273 · Johnson & Johnson · Neurology device
Download Printable Device Report (PDF)
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Jan 2012
Decision
81d
Days
Class 2
Risk

K113273 is an FDA 510(k) clearance for the SPOTLIGHT ACCESS SYSTEM. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Johnson & Johnson (Raynham, US). The FDA issued a Cleared decision on January 27, 2012 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4800 - 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.

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FDA 510(k) Submission Details - K113273

510(k) Number K113273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2011
Decision Date January 27, 2012
Days to Decision 81 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 148d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZT Device Classification - Class 2, Special Controls

Product Code GZT Retractor, Self-retaining, For Neurosurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4800
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 - GZT Retractor, Self-retaining, For Neurosurgery

All 20
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K113273.
MindsEye Expandable Port
K202072 · Minnetronix Neuro, Inc. · Aug 2020
Geister retractor for neuro - and spine surgery
K180610 · Geister Medizin Technik GmbH · Aug 2018
MEDICON Spinal Spreading Systems
K161680 · Medicon EG · Mar 2017
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · KARL STORZ Endoscopy-America, Inc. · Nov 2010
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
K090272 · Cardinal Health, Inc. · Mar 2009
PIPELINE II ACCESS SYSTEM
K062814 · Depuy Spine, Inc. · Dec 2006