Cleared Traditional

K932094 - BOVIE ULTRASONIC SURGICAL ASPIRATOR (FDA 510(k) Clearance)

K932094 · Mdt Corp., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
82d
Days
-
Risk

K932094 is an FDA 510(k) clearance for the BOVIE ULTRASONIC SURGICAL ASPIRATOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Mdt Corp., Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 21, 1993 after a review of 82 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 Mdt Corp., Inc. devices

Submission Details

510(k) Number K932094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1993
Decision Date July 21, 1993
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 114d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 156
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