Cleared Traditional

K003824 - OMNISONICS ULTRASONIC SURGERY SYSTEM

K003824 · Omnisonics Medical Technologies · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
87d
Days
-
Risk

K003824 is an FDA 510(k) clearance for the OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Omnisonics Medical Technologies (Wilmington, US). The FDA issued a Cleared decision on March 8, 2001 after a review of 87 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 Omnisonics Medical Technologies devices

FDA 510(k) Submission Details - K003824

510(k) Number K003824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2000
Decision Date March 08, 2001
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 89
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