Olympus Ultrasonic Surgical System
FDA 510(k) K031305 · Olympus Optical Co., Ltd.
510(k) numberK031305
Submission
- Device name
- Olympus Ultrasonic Surgical System
- Applicant
- Olympus Optical Co., Ltd.
Melville, NY, US - Received
- April 24, 2003
- Decision date
- September 23, 2003
- 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 |
|---|---|---|
| K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary…EOQ · Traditional | 10/16/2003SE |
| K032066 | Sonosurg SystemLFL · Traditional | 10/03/2003SE |
| K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type VEOB · Traditional | 07/24/2003SE |
| K032092 | Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional | 07/16/2003SE |
| K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8ODG · Traditional | 05/09/2003SE |
| K030194 | XUES-41 Endoscopic Electrosurgical UnitKNS · Traditional | 03/24/2003SE |
| K024138 | Heat Scissors Generator Set and Heat Scissors HandpieceGEI · Traditional | 03/12/2003SE |
| K021962 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 02/12/2003SE |
| K021852 | Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesGEI · Traditional | 02/11/2003SE |
| K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesEOQ · Traditional | 01/31/2003SE |
Questions and answers
When was Olympus Ultrasonic Surgical System cleared by the FDA?
Olympus Ultrasonic Surgical System (K031305) received a 510(k) decision of Substantially Equivalent on September 23, 2003, 152 days after the submission was received.
What is the product code of K031305?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.