Cleared Traditional

K040076 - ANSPACH ADVANCED MICRO SAW ATTACHMENTS (FDA 510(k) Clearance)

K040076 · The Anspach Effort, Inc. · Neurology device

Mar 2004

Decision

61d

Days

Class 2

Risk

K040076 is an FDA 510(k) clearance for the ANSPACH ADVANCED MICRO SAW ATTACHMENTS. This device is classified as 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 March 15, 2004, 61 days after receiving the submission on January 14, 2004.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K040076 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 14, 2004
Decision Date	March 15, 2004
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF