Cleared Traditional

K894387 - WESTCO MADAYAG PAB NEEDLE

K894387 is an FDA 510(k) clearance for WESTCO MADAYAG PAB NEEDLE, manufactured by Western Medical, Ltd.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K894387 · Western Medical, Ltd. · Neurology device
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Nov 1989
Decision
113d
Days
Class 2
Risk

K894387 is an FDA 510(k) clearance for the WESTCO MADAYAG PAB NEEDLE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Western Medical, Ltd. (San Diego, US). The FDA issued a Cleared decision on November 7, 1989 after a review of 113 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.

View all Western Medical, Ltd. devices

FDA 510(k) Submission Details - K894387

510(k) Number K894387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date November 07, 1989
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 148d · This submission: 113d
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 353
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K894387.
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
TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · Walter Lorenz Surgical, Inc. · Feb 1988
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K861629 · Downs Surgical , Ltd. · Aug 1986
DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
K851973 · Diasonics, Inc. · Jul 1985