Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P
FDA 510(k) K051036 · Ethicon Endo-Surgery, Inc.
510(k) numberK051036
Submission
- Device name
- Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- April 25, 2005
- Decision date
- June 2, 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
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| K233036 | Ultrasonic Surgical SystemLFL · Traditional | Hunan Handlike Minimally Invasive Surgery Co.… | 06/18/2024SE |
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| K231117 | neXus Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, LLC, A Bioventus Company | 06/23/2023SE |
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Questions and answers
When was Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P cleared by the FDA?
Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P (K051036) received a 510(k) decision of Substantially Equivalent on June 2, 2005, 38 days after the submission was received.
What is the product code of K051036?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.