Cleared Abbreviated

INSTRUMED RETRACTORS

K071771 · Instrumed International, Inc. · Neurology
Aug 2007
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K071771 is an FDA 510(k) clearance for the INSTRUMED RETRACTORS, a Retractor, Self-retaining, For Neurosurgery (Class II — Special Controls, product code GZT), submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 2, 2007, 34 days after receiving the submission on June 29, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4800.

Submission Details

510(k) Number K071771 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GZT — Retractor, Self-retaining, For Neurosurgery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4800

Similar Devices — GZT Retractor, Self-retaining, For Neurosurgery

All 42
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
NICO BrainPath
K172433 · Nico Corporation · Sep 2017
MEDICON Spinal Spreading Systems
K161680 · Medicon EG · Mar 2017