Cleared Traditional

K962952 - OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (FDA 510(k) Clearance)

K962952 · Olympus Optical, Co. · Neurology device
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Optimized for regulatory review, auditing and printing
Nov 1996
Decision
122d
Days
-
Risk

K962952 is an FDA 510(k) clearance for the OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU). Classified as Neurosurgical Ultrasonic Instruments (product code LBK).

Submitted by Olympus Optical, Co. (Great Neck,, US). The FDA issued a Cleared decision on November 29, 1996 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. 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.

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Submission Details

510(k) Number K962952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1996
Decision Date November 29, 1996
Days to Decision 122 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
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBK Neurosurgical Ultrasonic Instruments
Device Class -