Cleared Traditional

INSTRUMED RONGEUR

K081651 · Instrumed International, Inc. · Neurology
Aug 2008
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K081651 is an FDA 510(k) clearance for the INSTRUMED RONGEUR, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 8, 2008, 57 days after receiving the submission on June 12, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number K081651 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2008
Decision Date August 08, 2008
Days to Decision 57 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAE — Rongeur, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4840