Cleared Special

FHC MICROTARGETING DRIVE SYSTEM (K011992) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011992 · FHC, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
49d
Days
Class 2
Risk

K011992 is an FDA 510(k) clearance for the FHC MICROTARGETING DRIVE SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by FHC, Inc. (Bowdoinham, US). The FDA issued a Cleared decision on August 14, 2001 after a review of 49 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all FHC, Inc. devices

Submission Details

510(k) Number K011992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2001
Decision Date August 14, 2001
Days to Decision 49 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 148d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 160
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K011992.
MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
K012564 · Brainlab AG · Sep 2001
STRYKER NAVIGATION SYSTEM-KNEE MODULE
K010204 · Stryker Corp. · Aug 2001
VECTORVISION CT/FLUORO
K010968 · Brainlab AG · Aug 2001
VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
K003589 · Brainlab AG · May 2001
Z-TOUCH
K003268 · Brainlab AG · Feb 2001
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000