Cleared Special

K213824 - Sonopet iQ Ultrasonic Aspirator System

K213824 · Stryker Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K213824

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
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 159
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K213824.
Ultrasonic Scalpel System
K212614 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Jul 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221763 · Integra LifeSciences Corporation · Jul 2022
Oclet TDS 1000
K212049 · Tendonova Corporation · Mar 2022
neXus Ultrasonic Surgical Aspirator System
K212060 · Misonix, Inc. · Dec 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301 · Covidien, LLC · Nov 2021
Ultrasonic Surgical Aspirator System, Model: XD880B
K212750 · Smtp Technology Co., Ltd. · Sep 2021
K213824 · Sonopet iQ Ultrasonic Aspirator System
Download PDF FDA Summary Stryker Corporation