Selector Quantum Ultrasonic Aspirator System
FDA 510(k) K042277 · Integra Neurosciences, Ltd.
510(k) numberK042277
Submission
- Device name
- Selector Quantum Ultrasonic Aspirator System
- Applicant
- Integra Neurosciences, Ltd.
Andover Hampshire, GB - Received
- August 23, 2004
- Decision date
- September 29, 2004
- 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 |
More from Ethicon Endo-Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K082250 | Auragen Cortical Surface ElectrodesGYC · Special | 10/10/2008SE |
| K050720 | Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models…GWM · Special | 05/11/2005SE |
| K031086 | Camino Single Parameter Monitor, Model SPM-1GWM · Special | 05/14/2003SE |
| K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model Om 1530000M3LFL · Traditional | 09/13/2002SE |
| K022554 | Monitorr Icp External CSF Drainage and Monitoring SystemJXG · Special | 08/23/2002SE |
| K022553 | Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4LGWM · Special | 08/20/2002SE |
| K020558 | Licox CC1.G2 Brain Oxygen Catheter-MicroprobeGWM · Special | 03/21/2002SE |
| K002765 | Licox CMP MONITOR-AC3.1, Licox Imc Oxygen CATHETERS-CC1,CC1.SB Luicox Imc Introducer…GWM · Traditional | 11/24/2000SE |
Questions and answers
When was Selector Quantum Ultrasonic Aspirator System cleared by the FDA?
Selector Quantum Ultrasonic Aspirator System (K042277) received a 510(k) decision of Substantially Equivalent on September 29, 2004, 37 days after the submission was received.
What is the product code of K042277?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.