Cleared Traditional

K802140 - LEKSELL STEREOTACTIC SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K802140 · Downs Surgical , Ltd. · Radiology device
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Feb 1981
Decision
154d
Days
Class 1
Risk

K802140 is an FDA 510(k) clearance for the LEKSELL STEREOTACTIC SYSTEM. Classified as Holder, Head, Radiographic (product code IWY), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1981 after a review of 154 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1920 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Downs Surgical , Ltd. devices

Submission Details

510(k) Number K802140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1980
Decision Date February 05, 1981
Days to Decision 154 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 107d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWY Holder, Head, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1920
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.