Cleared Abbreviated

INSTRUMED RETRACTORS (K071771) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K071771 · Instrumed International, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
34d
Days
Class 2
Risk

K071771 is an FDA 510(k) clearance for the INSTRUMED RETRACTORS. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 2, 2007 after a review of 34 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Instrumed International, Inc. devices

Submission Details

510(k) Number K071771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2007
Decision Date August 02, 2007
Days to Decision 34 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 148d · This submission: 34d
Pathway characteristics
Standards-based clearance path.

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 K071771.
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Geister retractor for neuro - and spine surgery
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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