Cleared Traditional

K880814 - DX101 ULTRASONIC SURGICAL SYSTEM

K880814 · Niic U.S.A., Inc. · General & Plastic Surgery device
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Apr 1988
Decision
56d
Days
-
Risk

K880814 is an FDA 510(k) clearance for the DX101 ULTRASONIC SURGICAL SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Niic U.S.A., Inc. (Redwood City, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 56 days - a notably fast clearance cycle.

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: 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 Niic U.S.A., Inc. devices

FDA 510(k) Submission Details - K880814

510(k) Number K880814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1988
Decision Date April 13, 1988
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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