Sonosurg Trocar
FDA 510(k) K042160 · Aomori Olympus Co., Ltd.
510(k) numberK042160
Submission
- Device name
- Sonosurg Trocar
- Applicant
- Aomori Olympus Co., Ltd.
Melville, NY, US - Received
- August 10, 2004
- Decision date
- January 25, 2005
- 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 |
|---|---|---|
| K041566 | Sonosurg Ultrasonic Surgical SystemLFL · Traditional | 09/08/2004SE |
| K033333 | Single Use 3-LUMEN Balloon Catheter, Models B-230Q-A and B-230Q-BFGE · Special | 11/14/2003SE |
| K031523 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 10/01/2003SE |
| K031710 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 08/29/2003SE |
| K021672 | Pancreatic Drainage TubeFGE · Traditional | 04/16/2003SE |
| K022446 | Mucus Collection Probe, Models BC-401C & BC-402CEOQ · Traditional | 03/28/2003SE |
Questions and answers
When was Sonosurg Trocar cleared by the FDA?
Sonosurg Trocar (K042160) received a 510(k) decision of Substantially Equivalent on January 25, 2005, 168 days after the submission was received.
What is the product code of K042160?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.