Cleared Traditional

K936019 - NOMOS STEREOTACTIC BIOPSY INSTRUMENTS

K936019 is an FDA 510(k) clearance for NOMOS STEREOTACTIC BIOPSY INSTRUMENTS, manufactured by Nomos Corp.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K936019 · Nomos Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
95d
Days
Class 2
Risk

K936019 is an FDA 510(k) clearance for the NOMOS STEREOTACTIC BIOPSY INSTRUMENTS. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Nomos Corp. (Sewickley, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 95 days - within the typical 510(k) review window.

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 - K936019

510(k) Number K936019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1993
Decision Date March 22, 1994
Days to Decision 95 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
54d faster than avg
Panel avg: 149d · This submission: 95d
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 402
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K936019.
CRW-1 SYSTEM
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LEKSELL SURGIPLAN
K943468 · Elekta Instruments, Inc. · Jan 1995
GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
K931991 · Nomos Corp. · Aug 1993
AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
K924348 · Ad-Tech Medical Instrument Corp · Nov 1992
COOK STEREOTAXIC GUIDE
K900200 · Cook, Inc. · May 1990