The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Vapr Tripolar Suction Electrode.
| Device ID | K143475 |
| 510k Number | K143475 |
| Device Name: | VAPR Tripolar Suction Electrode |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
| Contact | Susan Kagan |
| Correspondent | Susan Kagan Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-05 |
| Decision Date | 2015-04-03 |
| Summary: | summary |