Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console Model
FDA 510(k) K983199 · Fibra Sonics, Inc.
510(k) numberK983199
Submission
- Device name
- Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console Model
- Applicant
- Fibra Sonics, Inc.
Chicago, IL, US - Received
- September 14, 1998
- Decision date
- December 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K993046 | Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model LS-2000FEO · Traditional | 11/22/1999SE |
| K984199 | ExonixIMI · Traditional | 02/17/1999SE |
| K984143 | Fibra-Sonics Phaco III or Iiip Fragmentation SystemHQC · Traditional | 02/16/1999SE |
| K980930 | Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 UsstaLFL · Traditional | 09/22/1998SE |
| K842024 | Ultrasonic Lithotriptor 300AFEO · Traditional | 12/11/1984SE |
| K834453 | Phaco Fragmentor GT-1HQC · Traditional | 03/16/1984SE |
| K813389 | Ultrasonic FragmentorHQE · Traditional | 02/04/1982SE |
| K812909 | Hygientist; Cycloson I & II; RetrofitELC · Traditional | 12/14/1981SE |
| K802381 | Lewicky Anterior Chamber Mainten. Sys.HQC · Traditional | 12/17/1980SE |
Questions and answers
When was Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console Model cleared by the FDA?
Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console Model (K983199) received a 510(k) decision of Substantially Equivalent on December 14, 1998, 91 days after the submission was received.
What is the product code of K983199?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.