Cleared Traditional

STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000

K071482 · Synergetics, Inc. · Neurology
Dec 2007
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K071482 is an FDA 510(k) clearance for the STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000, a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Synergetics, Inc. (O' Fallon, US). The FDA issued a Cleared decision on December 20, 2007, 204 days after receiving the submission on May 30, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number K071482 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2007
Decision Date December 20, 2007
Days to Decision 204 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXD — Generator, Lesion, Radiofrequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4400

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