Cleared Traditional

K190070 - Sonopet iQ Ultrasonic Aspirator System
(FDA 510(k) Clearance)

K190070 · Stryker Corporation · General & Plastic Surgery
Apr 2019
Decision
86d
Days
Risk

K190070 is an FDA 510(k) clearance for the Sonopet iQ Ultrasonic Aspirator System, a Instrument, Ultrasonic Surgical, submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on April 11, 2019, 86 days after receiving the submission on January 15, 2019. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K190070 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2019
Decision Date April 11, 2019
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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