Cleared Traditional

K223770 - Sonopet 1Q 3 7cm 1Q Large (FDA 510(k) Clearance)

Feb 2023
Decision
63d
Days
Risk

K223770 is an FDA 510(k) clearance for the Sonopet 1Q 3 7cm 1Q Large. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on February 16, 2023, 63 days after receiving the submission on December 15, 2022.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K223770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2022
Decision Date February 16, 2023
Days to Decision 63 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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