Cleared Traditional

K801623 - CAVITRON ULTRASONIC SURG. ASPIR. CUSA (FDA 510(k) Clearance)

K801623 · Cavitron Corp. · General & Plastic Surgery device
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Nov 1980
Decision
126d
Days
-
Risk

K801623 is an FDA 510(k) clearance for the CAVITRON ULTRASONIC SURG. ASPIR. CUSA. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on November 18, 1980 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K801623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date November 18, 1980
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 114d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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