Cleared Traditional

K161318 - Phantom Fukushima Neurological Holding ...

K161318 is an FDA 510(k) clearance for Phantom Fukushima Neurological Holding ..., manufactured by Tedan Surgical Innovations, LLC. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 313-day FDA review.

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

FDA 510(k) Submission Details - K161318

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.

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 17
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