K971861 - ULTRASONIC HAND INSTRUMENTS (FDA 510(k) Clearance)

K971861 is an FDA 510(k) clearance for the ULTRASONIC HAND INSTRUMENTS. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on July 1, 1997 after a review of 42 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 United States Surgical, A Division of Tyco Healthc devices