Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07
FDA 510(k) K002906 · Ethicon Endo-Surgery, Inc.
510(k) numberK002906
Submission
- Device name
- Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- September 18, 2000
- Decision date
- December 15, 2000
- 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 Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07 cleared by the FDA?
Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07 (K002906) received a 510(k) decision of Substantially Equivalent on December 15, 2000, 88 days after the submission was received.
What is the product code of K002906?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.