Cleared Traditional

K851659 - SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE

K851659 is the FDA 510(k) clearance for SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE by Medco Products, Co., Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K851659 · Medco Products, Co., Inc. · Neurology device
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Jul 1985
Decision
69d
Days
Class 2
Risk

K851659 is an FDA 510(k) clearance for the SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medco Products, Co., Inc. (Cooperstown, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medco Products, Co., Inc. devices

Submission Details

510(k) Number K851659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date July 01, 1985
Days to Decision 69 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 148d · This submission: 69d
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 226
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K851659.
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
MENISCECTOMY TRAY #9715
K823424 · Concept, Inc. · Mar 1983