Cleared Traditional

K190887 - Leksell Vantage Stereotactic System

K190887 is an FDA 510(k) clearance for Leksell Vantage Stereotactic System, manufactured by Elekta Instrument AB. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K190887 · Elekta Instrument AB · Neurology device
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Aug 2019
Decision
119d
Days
Class 2
Risk

K190887 is an FDA 510(k) clearance for the Leksell Vantage Stereotactic System. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on August 1, 2019 after a review of 119 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 Elekta Instrument AB devices

FDA 510(k) Submission Details - K190887

510(k) Number K190887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2019
Decision Date August 01, 2019
Days to Decision 119 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 148d · This submission: 119d
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 331
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