Cleared Traditional

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

K223770 · Stryker Corporation · General & Plastic Surgery device

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Feb 2023

Decision

63d

Days

Risk

K223770 is an FDA 510(k) clearance for the Sonopet 1Q 3 7cm 1Q Large. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on February 16, 2023 after a review of 63 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.

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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
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No