Cleared Traditional

K161318 - Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161318 · Tedan Surgical Innovations, LLC · Neurology device
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Mar 2017
Decision
313d
Days
Class 2
Risk

K161318 is an FDA 510(k) clearance for the Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurologi.... Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Tedan Surgical Innovations, LLC (Sugar Land, US). The FDA issued a Cleared decision on March 20, 2017 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Tedan Surgical Innovations, LLC devices

Submission Details

510(k) Number K161318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2016
Decision Date March 20, 2017
Days to Decision 313 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 148d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K161318.
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
K210615 · Thompson Surgical Instruments, Inc. · May 2022
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
K202694 · Vycor Medical, Inc. · Jan 2021
MindsEye Expandable Port
K202072 · Minnetronix Neuro, Inc. · Aug 2020