Cleared Abbreviated

K071771 - INSTRUMED RETRACTORS

K071771 is an FDA 510(k) clearance for INSTRUMED RETRACTORS, manufactured by Instrumed International, Inc.. The device is a Class 2 Neurology device with product code GZT cleared through the Abbreviated 510(k) pathway after a 34-day FDA review.

K071771 · Instrumed International, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071771

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 149d · This submission: 34d
Pathway characteristics
Standards-based clearance path.

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 39
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K071771.
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K090272 · Cardinal Health, Inc. · Mar 2009
FLEX ARM RETRACTOR SYSTEM
K071338 · Koros USA, Inc. · May 2007
PIPELINE II ACCESS SYSTEM
K062814 · Depuy Spine, Inc. · Dec 2006
VYCOR SURGICAL ACCESS SYSTEMS
K060973 · Vycor Medical, LLC · Jul 2006
K071771 · INSTRUMED RETRACTORS
Download PDF FDA Summary Instrumed Internation…