Omnisonics Ultrasonic Surgery System, Model Sti
FDA 510(k) K003824 · Omnisonics Medical Technologies
510(k) numberK003824
Submission
- Device name
- Omnisonics Ultrasonic Surgery System, Model Sti
- Applicant
- Omnisonics Medical Technologies
Wilmington, MA, US - Received
- December 11, 2000
- Decision date
- March 8, 2001
- 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 |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | Stryker Instruments | 03/24/2025SE |
| 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 |
More from Ethicon Endo-Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K083335 | Modified Omniwave Endovascular SystemQEY · Special | 12/15/2008SE |
| K071762 | Omniwave Endovascular SystemQEY · Traditional | 09/27/2007SE |
| K052428 | Resolution Endovascular SystemQEY · Traditional | 12/08/2005SE |
| K041705 | Resolution Thrombectomy System, Model EV-2QEY · Traditional | 09/01/2004SE |
| K993628 | Omnisonics Ultrasonic ProbesLFL · Traditional | 12/15/1999SE |
| K993445 | Omnisonic Endoscopic DeflectorGCM · Traditional | 12/06/1999SE |
| K991377 | Omnisonics Flexible Fiber Optic Endoscope and CouplerGCJ · Traditional | 07/12/1999SE |
Questions and answers
When was Omnisonics Ultrasonic Surgery System, Model Sti cleared by the FDA?
Omnisonics Ultrasonic Surgery System, Model Sti (K003824) received a 510(k) decision of Substantially Equivalent on March 8, 2001, 87 days after the submission was received.
What is the product code of K003824?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.