Selector Ultrasonic Surgical Aspirator
FDA 510(k) K901974 · Spembly Medical , Ltd.
510(k) numberK901974
Submission
- Device name
- Selector Ultrasonic Surgical Aspirator
- Applicant
- Spembly Medical , Ltd.
England, GB - Received
- May 1, 1990
- Decision date
- September 5, 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 |
|---|---|---|
| K925129 | SelectorGCJ · Traditional | 04/23/1993SE |
| K903303 | Spembly Medical 242 Cryounit/Series 242 CryoprobesHPS · Traditional | 10/11/1990SE |
| K882568 | 130 Cryo Unit & Assoc. Cryoprobes & SprayGEH · Traditional | 09/27/1988SE |
| K882963 | Spembly Medical 142 Cryo UnitGEH · Traditional | 08/08/1988SE |
| K882962 | Series 40 & Series 42 Cryoprobes (R Series)GEH · Traditional | 08/08/1988SE |
| K874367 | Various Cardiac Cryoprobes Having Dia. & Cos. DiffHQO · Traditional | 01/04/1988SE |
| K840497 | Obstetric Pulsar Two Channel TENSGZJ · Traditional | 04/16/1984SE |
| K832385 | Cryoprobes MC-1400-CRYOSURG-CONSOLEGEH · Traditional | 09/12/1983SE |
| K832334 | Cryomedics 5000 Cryosurgical ConsoleGEH · Traditional | 08/12/1983SE |
| K832140 | Cryomedics 5000 CryoprobesGEH · Traditional | 08/12/1983SE |
Questions and answers
When was Selector Ultrasonic Surgical Aspirator cleared by the FDA?
Selector Ultrasonic Surgical Aspirator (K901974) received a 510(k) decision of Substantially Equivalent on September 5, 1990, 127 days after the submission was received.
What is the product code of K901974?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.