Cleared Traditional

K000927 - ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4

K000927 · Misonix, Inc. · General & Plastic Surgery device
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Oct 2000
Decision
202d
Days
-
Risk

K000927 is an FDA 510(k) clearance for the ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on October 10, 2000 after a review of 202 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 Misonix, Inc. devices

FDA 510(k) Submission Details - K000927

510(k) Number K000927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2000
Decision Date October 10, 2000
Days to Decision 202 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 115d · This submission: 202d
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 145
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