Sonicision Cordless Ultrasonic Dissection Device
FDA 510(k) K153371 · Covidien, LLC
510(k) numberK153371
Submission
- Device name
- Sonicision Cordless Ultrasonic Dissection Device
- Applicant
- Covidien, LLC
Boulder, CO, US - Received
- November 23, 2015
- Decision date
- March 28, 2016
- 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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| K221790 | HARMONIC 700 ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2023SE |
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Questions and answers
When was Sonicision Cordless Ultrasonic Dissection Device cleared by the FDA?
Sonicision Cordless Ultrasonic Dissection Device (K153371) received a 510(k) decision of Substantially Equivalent on March 28, 2016, 126 days after the submission was received.
What is the product code of K153371?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.