Cleared Traditional

K040076 - ANSPACH ADVANCED MICRO SAW ATTACHMENTS

K040076 is the FDA 510(k) clearance for ANSPACH ADVANCED MICRO SAW ATTACHMENTS by The Anspach Effort, Inc.. It is a Class 2 Neurology device (product code HBE) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K040076 · The Anspach Effort, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
61d
Days
Class 2
Risk

K040076 is an FDA 510(k) clearance for the ANSPACH ADVANCED MICRO SAW ATTACHMENTS. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on March 15, 2004 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Anspach Effort, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 148d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 40
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K040076.
TWIST DRILL
K062842 · Walter Lorenz Surgical, Inc. · Dec 2006
ANSPACH COUPLER
K050628 · The Anspach Effort, Inc. · Apr 2005
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
K042783 · The Anspach Effort, Inc. · Dec 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · Stryker Instruments · Jan 2004
CRANIOCUT
K022942 · Aesculap, Inc. · Oct 2002
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · The Anspach Effort, Inc. · Oct 2000