Cleared Traditional

K971580 - UAS ULTRASONIC ASPIRATOR SYSTEM

K971580 · Wells Johnson Co. · General & Plastic Surgery device
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Dec 1997
Decision
223d
Days
-
Risk

K971580 is an FDA 510(k) clearance for the UAS ULTRASONIC ASPIRATOR SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on December 9, 1997 after a review of 223 days - an extended review 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: 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 Wells Johnson Co. devices

FDA 510(k) Submission Details - K971580

510(k) Number K971580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1997
Decision Date December 09, 1997
Days to Decision 223 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
108d slower than avg
Panel avg: 115d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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