Modification to Alliger Ultrasonic Surgical System, Model AUSS-4
FDA 510(k) K982841 · Misonix, Inc.
510(k) numberK982841
Submission
- Device name
- Modification to Alliger Ultrasonic Surgical System, Model AUSS-4
- Applicant
- Misonix, Inc.
Great Neck, NY, US - Received
- August 12, 1998
- Decision date
- September 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/30/2026SE |
| K221235 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/28/2022SE |
| K212060 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 12/13/2021SE |
| K190160 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 05/30/2019SE |
| K123980 | Sonicone Plus Ultrasound Wound Care System and AccessoriesNRB · Special | 03/05/2013SE |
| K112782 | Misonix Sonicone(R) Ultrasonic Wound Care System and AccessoriesNRB · Traditional | 12/01/2011SE |
| K070779 | Sonatherm 600I Ultrasonic Lesion Generating SystemNTB · Traditional | 07/09/2008SE |
| K070313 | Misonix, Inc., AUSS-7 Ultrasonic Surgical Aspirator SystemLFL · Special | 05/11/2007SE |
| K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RFLFL · Traditional | 10/26/2006SE |
| K042096 | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemNTB · Traditional | 01/26/2006SE |
Questions and answers
When was Modification to Alliger Ultrasonic Surgical System, Model AUSS-4 cleared by the FDA?
Modification to Alliger Ultrasonic Surgical System, Model AUSS-4 (K982841) received a 510(k) decision of Substantially Equivalent on September 4, 1998, 23 days after the submission was received.
What is the product code of K982841?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.