Cleared Traditional

K852662 - GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY

K852662 is the FDA 510(k) clearance for GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY by Neurosurgical Devices, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K852662 · Neurosurgical Devices, Inc. · Neurology device
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Aug 1985
Decision
58d
Days
Class 2
Risk

K852662 is an FDA 510(k) clearance for the GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Neurosurgical Devices, Inc. (Norfolk, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 58 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 Neurosurgical Devices, Inc. devices

Submission Details

510(k) Number K852662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1985
Decision Date August 21, 1985
Days to Decision 58 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 148d · This submission: 58d
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 K852662.
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
MENISCECTOMY TRAY #9715
K823424 · Concept, Inc. · Mar 1983