The following data is part of a premarket notification filed by Covidien Llc with the FDA for Barrx Anorectal Rfa Wand.
| Device ID | K162802 |
| 510k Number | K162802 |
| Device Name: | Barrx Anorectal RFA Wand |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN LLC 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Rachel Silva |
| Correspondent | Rachel Silva COVIDIEN LLC 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-05 |
| Decision Date | 2017-01-24 |
| Summary: | summary |