The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple Lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide.
| Device ID | K180149 |
| 510k Number | K180149 |
| Device Name: | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple Lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Covidien, Llc 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer Covidien, Llc 5920 Longbow Drive Boulder, CO 80301 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521592865 | K180149 | 000 |
| 10884521592896 | K180149 | 000 |
| 10884521592889 | K180149 | 000 |
| 20884521592855 | K180149 | 000 |
| 20884521592848 | K180149 | 000 |
| 20884521592831 | K180149 | 000 |
| 20884521592824 | K180149 | 000 |
| 10884521781627 | K180149 | 000 |
| 20884521592909 | K180149 | 000 |