Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k) K243930 · Stryker Instruments
510(k) numberK243930
Submission
- Device name
- Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
- Applicant
- Stryker Instruments
Portage, MI, US - Received
- December 20, 2024
- Decision date
- March 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Device class
- Unclassified
Other 510(k)s with product code LFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, LLC | 07/30/2026SE |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 10/08/2025SE |
| K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic…LFL · Traditional | Shanghai Saints Sages Surgical Co., Ltd. | 06/18/2025SE |
| K241700 | Tenex 2nd Generation SystemLFL · Traditional | Trice Medical, Inc. | 11/18/2024SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2024SE |
| K233036 | Ultrasonic Surgical SystemLFL · Traditional | Hunan Handlike Minimally Invasive Surgery Co.… | 06/18/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2023SE |
| K231117 | neXus Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, LLC, A Bioventus Company | 06/23/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2023SE |
| K223770 | Sonopet 1Q 3 7cm 1Q LargeLFL · Traditional | Stryker Corporation | 02/16/2023SE |
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Questions and answers
When was Sonopet iQ Ultrasonic Aspirator System (5500-050-000) cleared by the FDA?
Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (K243930) received a 510(k) decision of Substantially Equivalent on March 24, 2025, 94 days after the submission was received.
What is the product code of K243930?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.