Cleared Traditional

K980930 - FIBRA SONICS ULTRASONIC SURGICAL ASPIRA...

K980930 · Fibra Sonics, Inc. · General & Plastic Surgery device
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Sep 1998
Decision
194d
Days
-
Risk

K980930 is an FDA 510(k) clearance for the FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Fibra Sonics, Inc. (Chicago, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 194 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 Fibra Sonics, Inc. devices

FDA 510(k) Submission Details - K980930

510(k) Number K980930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1998
Decision Date September 22, 1998
Days to Decision 194 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
79d slower than avg
Panel avg: 115d · This submission: 194d
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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K970471 · Mentor Corp. · Jul 1997