Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model WAVE18S; Harmonic Disposable Torque Wrench
FDA 510(k) K062000 · Ethicon Endo-Surgery, Inc.
510(k) numberK062000
Submission
- Device name
- Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model WAVE18S; Harmonic Disposable Torque Wrench
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- July 17, 2006
- Decision date
- September 25, 2006
- 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
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| 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 |
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Questions and answers
When was Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model WAVE18S; Harmonic Disposable Torque Wrench cleared by the FDA?
Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model WAVE18S; Harmonic Disposable Torque Wrench (K062000) received a 510(k) decision of Substantially Equivalent on September 25, 2006, 70 days after the submission was received.
What is the product code of K062000?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.