Cleared Traditional

K883522 - AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT

K883522 · Amerimed US Corp. · Neurology device
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Sep 1988
Decision
44d
Days
-
Risk

K883522 is an FDA 510(k) clearance for the AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT. Classified as Neurosurgical Ultrasonic Instruments (product code LBK).

Submitted by Amerimed US Corp. (Denver, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 44 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 Amerimed US Corp. devices

FDA 510(k) Submission Details - K883522

510(k) Number K883522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1988
Decision Date September 30, 1988
Days to Decision 44 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 148d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

LBK Device Classification - Class 0,

Product Code LBK Neurosurgical Ultrasonic Instruments
Device Class -

Regulatory Peers - LBK Neurosurgical Ultrasonic Instruments

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