Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 Ussta
FDA 510(k) K980930 · Fibra Sonics, Inc.
510(k) numberK980930
Submission
- Device name
- Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 Ussta
- Applicant
- Fibra Sonics, Inc.
Chicago, IL, US - Received
- March 12, 1998
- Decision date
- September 22, 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 |
| K983199 | Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console ModelLFL · Traditional | 12/14/1998SE |
| 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 2100 Ussta cleared by the FDA?
Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 Ussta (K980930) received a 510(k) decision of Substantially Equivalent on September 22, 1998, 194 days after the submission was received.
What is the product code of K980930?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.