510(k) K180149 ยท LFL Instrument, Ultrasonic Surgical
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Mar 26, 2018 |
| Received | Jan 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180149
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2021 | Covidien Llc Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status
Item Code: CBCA Open, Classified |
LFL | None listed |
| Jun 23, 2021 | Covidien Llc Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade.
Product Number: SCGAA Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.