Cusa System 200C Ultrasonic Aspirator/Cusa System 200T Ultrasonic Aspirator/Cusa Lap Accessory
FDA 510(k) K964601 · Valleylab, Inc.
510(k) numberK964601
Submission
- Device name
- Cusa System 200C Ultrasonic Aspirator/Cusa System 200T Ultrasonic Aspirator/Cusa Lap Accessory
- Applicant
- Valleylab, Inc.
Boulder, CO, US - Received
- November 18, 1996
- Decision date
- January 16, 1997
- 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 |
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| K053535 | Vivawave Microwave Ablation SystemNEY · Traditional | 04/27/2006SE |
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| K052796 | Cool-Tip RF Generator, Cool-Tip RF System AccessoriesGEI · Traditional | 02/03/2006SE |
| K051644 | Valleylab Forcetriad Electrosurgical GeneratorGEI · Traditional | 08/11/2005SE |
| K051627 | Valleylab G3000 Electrosurgical InstrumentGEI · Traditional | 07/22/2005SE |
| K043273 | Ligasure Vessel Sealing System. Ligasure InstrumentsGEI · Traditional | 01/05/2005SE |
| K042216 | Cool-Tip RF Ablation SystemGEI · Traditional | 11/12/2004SE |
| K041587 | Ligasure Precise Model #LS1200/LIGASURE 5MM Laparoscopic Sealer Divider Model # LS1500GEI · Traditional | 09/28/2004SE |
Questions and answers
When was Cusa System 200C Ultrasonic Aspirator/Cusa System 200T Ultrasonic Aspirator/Cusa Lap Accessory cleared by the FDA?
Cusa System 200C Ultrasonic Aspirator/Cusa System 200T Ultrasonic Aspirator/Cusa Lap Accessory (K964601) received a 510(k) decision of Substantially Equivalent on January 16, 1997, 59 days after the submission was received.
What is the product code of K964601?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.