Cleared Special

K213824 - Sonopet iQ Ultrasonic Aspirator System (FDA 510(k) Clearance)

K213824 · Stryker Corporation · General & Plastic Surgery device

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Feb 2022

Decision

57d

Days

Risk

K213824 is an FDA 510(k) clearance for the Sonopet iQ Ultrasonic Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on February 3, 2022 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number	K213824 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No