Cleared Traditional

K861629 - KOMAI CT-STEREOTACTIC APPARATUS AND ACC...

K861629 is an FDA 510(k) clearance for KOMAI CT-STEREOTACTIC APPARATUS AND ACC..., manufactured by Downs Surgical , Ltd.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K861629 · Downs Surgical , Ltd. · Neurology device
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Aug 1986
Decision
105d
Days
Class 2
Risk

K861629 is an FDA 510(k) clearance for the KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on August 12, 1986 after a review of 105 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K861629

510(k) Number K861629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date August 12, 1986
Days to Decision 105 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 148d · This submission: 105d
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 241
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K861629.
STEALTHSTATION
K954276 · Surgical Navigation Technologies, Inc. · Jan 1996
COOK STEREOTAXIC GUIDE
K900200 · Cook, Inc. · May 1990
TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · Walter Lorenz Surgical, Inc. · Feb 1988
DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
K851973 · Diasonics, Inc. · Jul 1985
MENISCECTOMY TRAY #9715
K823424 · Concept, Inc. · Mar 1983