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FDA 510(k), K180149, Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
FDA 510(k), K180149, Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
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510(K) Number: K180149
Device Name: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
Manufacturer: Covidien, llc
Device Classification Name: instrument, ultrasonic surgical
Regulation Number:
Classification Product Code: LFL
Date Received: 01/19/2018
Decision Date: 03/26/2018
Regulation Medical Specialty:
Device Name: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
Manufacturer: Covidien, llc
Device Classification Name: instrument, ultrasonic surgical
Regulation Number:
Classification Product Code: LFL
Date Received: 01/19/2018
Decision Date: 03/26/2018
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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