Cleared Traditional

CRANIAL PERFORATOR

K082637 · The Anspach Effort, Inc. · Neurology
Dec 2008
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K082637 is an FDA 510(k) clearance for the CRANIAL PERFORATOR, a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II — Special Controls, product code HBF), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on December 22, 2008, 103 days after receiving the submission on September 10, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4305.

Submission Details

510(k) Number K082637 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2008
Decision Date December 22, 2008
Days to Decision 103 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBF — Drills, Burrs, Trephines & Accessories (compound, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4305

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