Sonicision Cordless Ultrasonic Dissector
FDA 510(k) K141371 · Covidien, Formerly Valleylab, A Division of Tyco H
510(k) numberK141371
Submission
- Device name
- Sonicision Cordless Ultrasonic Dissector
- Applicant
- Covidien, Formerly Valleylab, A Division of Tyco H
Boulder, CO, US - Received
- May 27, 2014
- Decision date
- August 7, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)GEI · Traditional | 12/20/2013SE |
| K131170 | Sonicision Sterilization TrayKCT · Traditional | 08/28/2013SE |
| K123444 | Ligasure Impact Curved, Large Jaw, Open Sealer / DividerGEI · Traditional | 01/30/2013SE |
| K113572 | Ligasure Curved, Small Jaw, Open Sealer/DividerGEI · Traditional | 09/05/2012SE |
| K102913 | ForcetriadGEI · Special | 05/06/2011SE |
Questions and answers
When was Sonicision Cordless Ultrasonic Dissector cleared by the FDA?
Sonicision Cordless Ultrasonic Dissector (K141371) received a 510(k) decision of Substantially Equivalent on August 7, 2014, 72 days after the submission was received.
What is the product code of K141371?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.