Cleared Traditional

K120691 - BRAIN PORT

K120691 is an FDA 510(k) clearance for BRAIN PORT, manufactured by Nico Corporation. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K120691 · Nico Corporation · Neurology device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
90d
Days
Class 2
Risk

K120691 is an FDA 510(k) clearance for the BRAIN PORT. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Nico Corporation (Indianapolis, US). The FDA issued a Cleared decision on June 5, 2012 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nico Corporation devices

FDA 510(k) Submission Details - K120691

510(k) Number K120691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2012
Decision Date June 05, 2012
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 149d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZT Retractor, Self-retaining, For Neurosurgery

All 33
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K120691.
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
K161318 · Tedan Surgical Innovations, LLC · Mar 2017
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
SPOTLIGHT ACCESS SYSTEM
K113273 · Johnson & Johnson · Jan 2012
SPOTLIGHT ACCESS SYSTEM
K112913 · Johnson & Johnson · Dec 2011
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · KARL STORZ Endoscopy-America, Inc. · Nov 2010