Cleared Traditional

K884412 - CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (FDA 510(k) Clearance)

K884412 · Valleylab, Inc. · Neurology device
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Dec 1988
Decision
43d
Days
-
Risk

K884412 is an FDA 510(k) clearance for the CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.. Classified as Neurosurgical Ultrasonic Instruments (product code LBK).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on December 2, 1988 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Neurology 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 Valleylab, Inc. devices

Submission Details

510(k) Number K884412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1988
Decision Date December 02, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 148d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBK Neurosurgical Ultrasonic Instruments
Device Class -