Cleared Traditional

K051724 - ACUMEN IMAGE GUIDED SURGICAL SYSTEM

K051724 is the FDA 510(k) clearance for ACUMEN IMAGE GUIDED SURGICAL SYSTEM by Ebi, L.P.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K051724 · Ebi, L.P. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
22d
Days
Class 2
Risk

K051724 is an FDA 510(k) clearance for the ACUMEN IMAGE GUIDED SURGICAL SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Ebi, L.P. devices

Submission Details

510(k) Number K051724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date July 19, 2005
Days to Decision 22 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
126d faster than avg
Panel avg: 148d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 225
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K051724.
DEPUY CAS HIP INSTRUMENTATION
K052178 · DePuy Orthopaedics, Inc. · Oct 2005
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
K050651 · Medtronic Navigation, Inc. · Jul 2005
ELEKTA ESARTE FRAME SYSTEM
K051746 · Elekta Instrument AB · Jul 2005
NAVIPRO SHOULDER SOFTWARE MODULE
K050897 · Kinamed, Inc. · May 2005
IPLAN! DIGITAL TEMPLATING
K042543 · Brainlab AG · May 2005
MODIFICATION TO: VOYAGER LINUX
K050973 · Mako Surgical Corp. · May 2005