Cleared Traditional

SONOTOME ULTRASONIC ASPIRATOR TIPS (K010637) - FDA 510(k) Clearance

K010637 · Synergetics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
46d
Days
-
Risk

K010637 is an FDA 510(k) clearance for the SONOTOME ULTRASONIC ASPIRATOR TIPS. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Synergetics, Inc. (St. Charles, US). The FDA issued a Cleared decision on April 20, 2001 after a review of 46 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 Synergetics, Inc. devices

Submission Details

510(k) Number K010637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date April 20, 2001
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
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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