Cleared Traditional

Anspach Helix Dissection Tools

K183545 · The Anspach Effort, Inc. · Neurology
Jul 2019
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K183545 is an FDA 510(k) clearance for the Anspach Helix 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 July 19, 2019, 211 days after receiving the submission on December 20, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K183545 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2018
Decision Date July 19, 2019
Days to Decision 211 days
Submission Type Traditional
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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