The following data is part of a premarket notification filed by Tva Medical, Inc. with the FDA for Esu-1 Electrosurgical Generator.
| Device ID | K162656 |
| 510k Number | K162656 |
| Device Name: | ESU-1 Electrosurgical Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TVA Medical, Inc. 7000 Bee Caves Rd., Suite 250 Austin, TX 78746 |
| Contact | Katherine Kumar |
| Correspondent | Katherine Kumar TVA Medical, Inc. 7000 Bee Caves Rd., Suite 250 Austin, TX 78746 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-23 |
| Decision Date | 2016-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868260000228 | K162656 | 000 |