Cleared Traditional

CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS. (K931902) - FDA 510(k) Clearance

K931902 · Valleylab, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
515d
Days
-
Risk

K931902 is an FDA 510(k) clearance for the CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on September 16, 1994 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Valleylab, Inc. devices

Submission Details

510(k) Number K931902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1993
Decision Date September 16, 1994
Days to Decision 515 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
400d slower than avg
Panel avg: 115d · This submission: 515d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 39
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