Cleared Traditional

K143420 - SYMBIS Surgical System

K143420 is an FDA 510(k) clearance for SYMBIS Surgical System, manufactured by Imris, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K143420 · Imris, Inc. · Neurology device
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Oct 2015
Decision
336d
Days
Class 2
Risk

K143420 is an FDA 510(k) clearance for the SYMBIS Surgical System. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Imris, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 30, 2015 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Imris, Inc. devices

FDA 510(k) Submission Details - K143420

510(k) Number K143420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2014
Decision Date October 30, 2015
Days to Decision 336 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 148d · This submission: 336d
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 269
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K143420.
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