Cleared Traditional

K855138 - BOVIE ULTRASONIC SURGICAL SYSTEM (FDA 510(k) Clearance)

K855138 · Clinical Technology Corp. · Neurology device
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Nov 1986
Decision
322d
Days
-
Risk

K855138 is an FDA 510(k) clearance for the BOVIE ULTRASONIC SURGICAL SYSTEM. Classified as Neurosurgical Ultrasonic Instruments (product code LBK).

Submitted by Clinical Technology Corp. (Rochester, US). The FDA issued a Cleared decision on November 10, 1986 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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.

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Submission Details

510(k) Number K855138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date November 10, 1986
Days to Decision 322 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 148d · This submission: 322d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBK Neurosurgical Ultrasonic Instruments
Device Class -