Cleared Traditional

K052840 - IGI-SYSTEM

K052840 is an FDA 510(k) clearance for IGI-SYSTEM, manufactured by Denx Advanced Dental Systems. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K052840 · Denx Advanced Dental Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
70d
Days
Class 2
Risk

K052840 is an FDA 510(k) clearance for the IGI-SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Denx Advanced Dental Systems (Jerusalem, Al, IL). The FDA issued a Cleared decision on December 16, 2005 after a review of 70 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 Denx Advanced Dental Systems devices

FDA 510(k) Submission Details - K052840

510(k) Number K052840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2005
Decision Date December 16, 2005
Days to Decision 70 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 148d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HAW Device Classification - Class 2, Special Controls

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 302
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K052840.
CI KNEE, CI MI TKR
K052966 · Brainlab AG · Feb 2006
IPLAN
K053127 · Brainlab AG · Feb 2006
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
K052425 · Zimmer, Inc. · Dec 2005
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
K052851 · Mako Surgical Corp. · Nov 2005
NAVIGATION SW HIP 3.1 ON CI
K052213 · Brainlab AG · Nov 2005
DEPUY CAS HIP INSTRUMENTATION
K052178 · DePuy Orthopaedics, Inc. · Oct 2005