Cleared Traditional

K010309 - SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR

K010309 · Mutoh America Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
76d
Days
-
Risk

K010309 is an FDA 510(k) clearance for the SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Mutoh America Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on April 18, 2001 after a review of 76 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 Mutoh America Co., Ltd. devices

FDA 510(k) Submission Details - K010309

510(k) Number K010309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2001
Decision Date April 18, 2001
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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 131
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