Cleared Traditional

ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM

K061297 · The Anspach Effort, Inc. · Neurology
Jan 2007
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K061297 is an FDA 510(k) clearance for the ANSPACH IMRI 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 January 26, 2007, 262 days after receiving the submission on May 9, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K061297 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2006
Decision Date January 26, 2007
Days to Decision 262 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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