Cleared Traditional

K910696 - CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR (FDA 510(k) Clearance)

K910696 · Valleylab, Inc. · General & Plastic Surgery device
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Jun 1991
Decision
112d
Days
-
Risk

K910696 is an FDA 510(k) clearance for the CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on June 11, 1991 after a review of 112 days - within the typical 510(k) review window.

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 Valleylab, Inc. devices

Submission Details

510(k) Number K910696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1991
Decision Date June 11, 1991
Days to Decision 112 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 114d · This submission: 112d
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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