Cleared Traditional

K010981 - GSA GENITO SENSORY ANALYZER

K010981 is an FDA 510(k) clearance for GSA GENITO SENSORY ANALYZER, manufactured by Medoc Ltd. Advanced Medical Systems. The device is a Class 1 Neurology device with product code LLN cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K010981 · Medoc Ltd. Advanced Medical Systems · Neurology device
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Sep 2001
Decision
171d
Days
Class 1
Risk

K010981 is an FDA 510(k) clearance for the GSA GENITO SENSORY ANALYZER. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Medoc Ltd. Advanced Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on September 20, 2001 after a review of 171 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1200 - 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 Medoc Ltd. Advanced Medical Systems devices

FDA 510(k) Submission Details - K010981

510(k) Number K010981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2001
Decision Date September 20, 2001
Days to Decision 171 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
23d slower than avg
Panel avg: 148d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

LLN Device Classification - Class 1, General Controls

Product Code LLN Device, Vibration Threshold Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1200
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.