Cleared Traditional

BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 (K880166) - FDA 510(k) Clearance

K880166 · Clinical Technology Corp. · General & Plastic Surgery device
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Feb 1988
Decision
35d
Days
-
Risk

K880166 is an FDA 510(k) clearance for the BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Clinical Technology Corp. (Baltimore, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clinical Technology Corp. devices

Submission Details

510(k) Number K880166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1988
Decision Date February 18, 1988
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 39
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