Cleared Special

Sonopet iQ Ultrasonic Aspirator System

K213824 · Stryker Corporation · General & Plastic Surgery
Feb 2022
Decision
57d
Days
Risk

About This 510(k) Submission

K213824 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 February 3, 2022, 57 days after receiving the submission on December 8, 2021. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K213824 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2021
Decision Date February 03, 2022
Days to Decision 57 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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