Uas Ultrasonic Aspirator System
FDA 510(k) K971580 · Wells Johnson Co.
510(k) numberK971580
Submission
- Device name
- Uas Ultrasonic Aspirator System
- Applicant
- Wells Johnson Co.
Tucson, AZ, US - Received
- April 30, 1997
- Decision date
- December 9, 1997
- 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K991437 | Wells Johnson Infusion System, Model 20-6000-00FRN · Traditional | 08/30/1999SE |
| K984448 | Bircoll Balloon DissectorFZW · Traditional | 01/28/1999SE |
| K945876 | Weco Endoscopic System with Fiber Optic LightEQH · Traditional | 12/04/1995SE |
| K945500 | Wells Johnson Fixation SystemJEY · Traditional | 09/21/1995SE |
| K951519 | Weco Endoscopic System with Fiber Optic LightFWL · Traditional | 06/14/1995SE |
| K945877 | Weco Endoscopic Systems with Fiber Optic LightHJM · Traditional | 03/02/1995SE |
| K945805 | Wells Johnson Weco Monopolar/Frazier Suction ProbeGEI · Traditional | 12/13/1994SE |
| K854068 | External Mechanical Fastener · Traditional | 11/22/1985SE |
| K843188 | Wells Johnson Co. Chaj-Chir-Suction TipJOL · Traditional | 09/20/1984SE |
| K832521 | Plastic Suction TipsGEA · Traditional | 10/20/1983SE |
Questions and answers
When was Uas Ultrasonic Aspirator System cleared by the FDA?
Uas Ultrasonic Aspirator System (K971580) received a 510(k) decision of Substantially Equivalent on December 9, 1997, 223 days after the submission was received.
What is the product code of K971580?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.