Cleared Traditional

PIPELINE II ACCESS SYSTEM (K062814) - FDA 510(k) Clearance

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

K062814 · Depuy Spine, Inc. · Neurology device
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Dec 2006
Decision
86d
Days
Class 2
Risk

K062814 is an FDA 510(k) clearance for the PIPELINE II ACCESS SYSTEM. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on December 15, 2006 after a review of 86 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.

View all Depuy Spine, Inc. devices

Submission Details

510(k) Number K062814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2006
Decision Date December 15, 2006
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
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 K062814.
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
Geister retractor for neuro - and spine surgery
K180610 · Geister Medizin Technik GmbH · Aug 2018
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · KARL STORZ Endoscopy-America, Inc. · Nov 2010
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
K895395 · Baxter Healthcare Corp · Oct 1989