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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 149d · 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 36
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K113273.
Self-retaining Retractor
K161004 · Fetzer Medical GmbH & Co. KG · Sep 2016
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
K150378 · Nico Corporation · Jun 2015
BRAIN PORT
K120691 · Nico Corporation · Jun 2012
SPOTLIGHT ACCESS SYSTEM
K112913 · Johnson & Johnson · Dec 2011
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
K113273 · SPOTLIGHT ACCESS SYSTEM
Download PDF FDA Summary Johnson & Johnson