Cavitron Ultrasonic Surg. Aspir. Cusa
FDA 510(k) K801623 · Cavitron Corp.
510(k) numberK801623
Submission
- Device name
- Cavitron Ultrasonic Surg. Aspir. Cusa
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- July 15, 1980
- Decision date
- November 18, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K811582 | The PlacerEID · Traditional | 07/28/1981SE |
| K810207 | Minor Surgery LightGBC · Traditional | 02/13/1981SE |
| K802928 | Spirometric Computer #SC-10BZC · Traditional | 12/17/1980SE |
| K801877 | Slit Lamp AttachmentHQB · Traditional | 09/16/1980SE |
| K800869 | Model PM-20(N)(R)CO2 Patient Monitor/AlaCCK · Traditional | 05/28/1980SE |
| K800722 | Auto-Field D Automated Visual DetectorHPT · Traditional | 04/29/1980SE |
| K791585 | Model G-61 Ultrasonic Dental UnitELC · Traditional | 09/19/1979SE |
| K791277 | Model 6500 Extraction Irrigation SysHDQ · Traditional | 08/22/1979SE |
| K782054 | Laser, CO2 SurgicalHHR · Traditional | 01/17/1979SE |
| K782065 | Laser, PhotocoagulationHQF · Traditional | 12/28/1978SE |
Questions and answers
When was Cavitron Ultrasonic Surg. Aspir. Cusa cleared by the FDA?
Cavitron Ultrasonic Surg. Aspir. Cusa (K801623) received a 510(k) decision of Substantially Equivalent on November 18, 1980, 126 days after the submission was received.
What is the product code of K801623?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.