Cleared Traditional

RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM (K964742) - FDA 510(k) Clearance

K964742 · Aziz Y. Anis, M.D. · General & Plastic Surgery device
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Apr 1997
Decision
147d
Days
-
Risk

K964742 is an FDA 510(k) clearance for the RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Aziz Y. Anis, M.D. (Temple City, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Aziz Y. Anis, M.D. devices

Submission Details

510(k) Number K964742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1996
Decision Date April 22, 1997
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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