Surgical Aspirator Kit
FDA 510(k) K904010 · Surgeon Surgical Instrumentation, Inc.
510(k) numberK904010
Submission
- Device name
- Surgical Aspirator Kit
- Applicant
- Surgeon Surgical Instrumentation, Inc.
Placentia, CA, US - Received
- August 29, 1990
- Decision date
- November 21, 1990
- 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 |
|---|---|---|
| K954241 | Surgin Genisis PhacoemulsifierHQC · Traditional | 12/01/1995SE |
| K932281 | Verres NeedleGCT · Traditional | 08/06/1993SE |
| K922038 | CO2 Insufflation TubingHIF · Traditional | 10/13/1992SE |
| K890447 | Hemorrhage OccludorGDW · Traditional | 02/23/1989SE |
| K880543 | Uni-PortKYG · Traditional | 07/01/1988SE |
| K881232 | Surgin Eye ShieldHOY · Traditional | 04/13/1988SE |
| K861203 | Multi-SpikeKYG · Traditional | 04/28/1986SE |
| K852229 | Sterile Eye Packs or Trays · Traditional | 06/07/1985SE |
| K830859 | I/A KitGBX · Traditional | 05/02/1983SE |
Questions and answers
When was Surgical Aspirator Kit cleared by the FDA?
Surgical Aspirator Kit (K904010) received a 510(k) decision of Substantially Equivalent on November 21, 1990, 84 days after the submission was received.
What is the product code of K904010?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.