Cleared Traditional

K983410 - @ TARGET

K983410 is the FDA 510(k) clearance for @ TARGET by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K983410 · Brainlab AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
354d
Days
Class 2
Risk

K983410 is an FDA 510(k) clearance for the @ TARGET. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Palo Alto, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab AG devices

Submission Details

510(k) Number K983410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1998
Decision Date September 17, 1999
Days to Decision 354 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 148d · This submission: 354d
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 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K983410.
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K991706 · Stryker Corp. · Dec 1999
VIEWPOINT ENT/ORTHOPEDIC OPTION
K991256 · Philips Medical Systems (Cleveland), Inc. · Oct 1999
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
K992882 · Elekta Instrument AB · Sep 1999
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
K992721 · Radionics, Inc. · Sep 1999
ELEKTA STEREOTACTIC GUIDE
K991636 · Elekta Instrument AB · Jul 1999
VIEWPOINT TOOLS- STERRAD
K983764 · Philips Medical Systems (Cleveland), Inc. · Jul 1999