Cleared Traditional

K952390 - BRAINLAB STEROTATIC HEADRING

K952390 is an FDA 510(k) clearance for BRAINLAB STEROTATIC HEADRING, manufactured by Brainlab Med. Computersysteme GmbH. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K952390 · Brainlab Med. Computersysteme GmbH · Neurology device
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Feb 1996
Decision
256d
Days
Class 2
Risk

K952390 is an FDA 510(k) clearance for the BRAINLAB STEROTATIC HEADRING. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab Med. Computersysteme GmbH (85586 Poing/Munchen, DE). The FDA issued a Cleared decision on February 2, 1996 after a review of 256 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.

View all Brainlab Med. Computersysteme GmbH devices

FDA 510(k) Submission Details - K952390

510(k) Number K952390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1995
Decision Date February 02, 1996
Days to Decision 256 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 148d · This submission: 256d
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 278
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K952390.
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
K961639 · Elekta Instrument AB · Jul 1996
MAYFIELD-ACCISS WORKSTATION
K955397 · Nomos Corp. · Apr 1996
CODMAN FIDUCIAL MARKER SYSTEM
K953568 · Codman & Shurtleff, Inc. · Feb 1996
STEALTHSTATION
K954276 · Surgical Navigation Technologies, Inc. · Jan 1996
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · Nomos Corp. · Mar 1994
GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
K931991 · Nomos Corp. · Aug 1993