Cleared Traditional

ANSPACH MRI SAFE SURGICAL DRILL SYSTEM

K040186 · The Anspach Effort, Inc. · Neurology
Apr 2004
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K040186 is an FDA 510(k) clearance for the ANSPACH MRI SAFE SURGICAL DRILL SYSTEM, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on April 15, 2004, 79 days after receiving the submission on January 27, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K040186 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2004
Decision Date April 15, 2004
Days to Decision 79 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

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