Cleared Traditional

K946033 - LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE

K946033 is an FDA 510(k) clearance for LEIBINGER STEREOPLAN PLUS STEROTACTIC T..., manufactured by Leibinger GmbH. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K946033 · Leibinger GmbH · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
266d
Days
Class 2
Risk

K946033 is an FDA 510(k) clearance for the LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Leibinger GmbH (Washington, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K946033

510(k) Number K946033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date September 01, 1995
Days to Decision 266 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
117d slower than avg
Panel avg: 149d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K946033.
STEALTHSTATION
K954276 · Surgical Navigation Technologies, Inc. · Jan 1996
CRW-1 SYSTEM
K944463 · Radionics Software Applications, Inc. · Oct 1995
REGULUS MEASUREMENT UNIT
K935456 · Compass Intl., Inc. · Oct 1995
STEREOPLAN
K946252 · Radionics Software Applications, Inc. · Mar 1995
LEKSELL SURGIPLAN
K943468 · Elekta Instruments, Inc. · Jan 1995
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · Nomos Corp. · Mar 1994
K946033 · LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE
Download PDF FDA Summary Leibinger GmbH