Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
FDA 510(k) K212301 · Covidien, LLC
510(k) numberK212301
Submission
- Device name
- Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
- Applicant
- Covidien, LLC
Boulder, CO, US - Received
- July 23, 2021
- Decision date
- November 15, 2021
- 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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Questions and answers
When was Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device cleared by the FDA?
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device (K212301) received a 510(k) decision of Substantially Equivalent on November 15, 2021, 115 days after the submission was received.
What is the product code of K212301?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.