Cleared Traditional

OMNISONICS ULTRASONIC PROBES (K993628) - FDA 510(k) Clearance

K993628 · Omnisonics Medical Technologies · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 1999
Decision
49d
Days
-
Risk

K993628 is an FDA 510(k) clearance for the OMNISONICS ULTRASONIC PROBES. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Omnisonics Medical Technologies (Hopkonton, US). The FDA issued a Cleared decision on December 15, 1999 after a review of 49 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

Submission Details

510(k) Number K993628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1999
Decision Date December 15, 1999
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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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