Cleared Traditional

K933559 - ALLIGER ULTRASONIC SURGICAL SYSTEM

K933559 · Medsonic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
85d
Days
-
Risk

K933559 is an FDA 510(k) clearance for the ALLIGER ULTRASONIC SURGICAL SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Medsonic, Inc. (Farmingdale, US). The FDA issued a Cleared decision on October 15, 1993 after a review of 85 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 Medsonic, Inc. devices

FDA 510(k) Submission Details - K933559

510(k) Number K933559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1993
Decision Date October 15, 1993
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 145
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