The following data is part of a premarket notification filed by Covidien Llc with the FDA for Barrx Flex Rfa Energy Generator.
| Device ID | K160360 |
| 510k Number | K160360 |
| Device Name: | Barrx FLEX RFA Energy Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Timothy Thomas |
| Correspondent | Gloria Dy Covidien Llc 540 Oakmead Parkway Sunnyvale, Ca 94085, CA 94085 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-09 |
| Decision Date | 2016-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521786035 | K160360 | 000 |
| 10884521181281 | K160360 | 000 |