Cleared Special

ANSPACH DISSECTION TOOLS

K113476 · The Anspach Effort, Inc. · Neurology
Dec 2011
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K113476 is an FDA 510(k) clearance for the ANSPACH DISSECTION TOOLS, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on December 16, 2011, 24 days after receiving the submission on November 22, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K113476 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2011
Decision Date December 16, 2011
Days to Decision 24 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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