The following data is part of a premarket notification filed by Trod Medical Sa with the FDA for Encage Bipolar Rf Probe.
| Device ID | K082954 |
| 510k Number | K082954 |
| Device Name: | ENCAGE BIPOLAR RF PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TROD MEDICAL SA 9 AVENUE DES MONTBOUCONS Besancon, FR 25000 |
| Contact | Celine Garcia |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-03 |
| Decision Date | 2008-10-17 |
| Summary: | summary |