Cleared Special

K112913 - SPOTLIGHT ACCESS SYSTEM

K112913 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 Special 510(k) pathway after a 74-day FDA review.

K112913 · Johnson & Johnson · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
74d
Days
Class 2
Risk

K112913 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 December 16, 2011 after a review of 74 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112913

510(k) Number K112913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date December 16, 2011
Days to Decision 74 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 149d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

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 36
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K112913.
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
K150378 · Nico Corporation · Jun 2015
BRAIN PORT
K120691 · Nico Corporation · Jun 2012
SPOTLIGHT ACCESS SYSTEM
K113273 · Johnson & Johnson · Jan 2012
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
INSTRUMED RETRACTORS
K071771 · Instrumed International, Inc. · Aug 2007
K112913 · SPOTLIGHT ACCESS SYSTEM
Download PDF FDA Summary Johnson & Johnson