Cleared Traditional

K884413 - CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (FDA 510(k) Clearance)

K884413 · Valleylab, Inc. · Neurology device
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Dec 1988
Decision
43d
Days
-
Risk

K884413 is an FDA 510(k) clearance for the CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR. 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 K884413 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 -