Cleared Traditional

K880815 - DX101-T ULTRASONIC SURGICAL SYSTEM

K880815 · Niic U.S.A., Inc. · General & Plastic Surgery device
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Apr 1988
Decision
56d
Days
-
Risk

K880815 is an FDA 510(k) clearance for the DX101-T 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 - K880815

510(k) Number K880815 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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R PAK
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