The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Joimax Endovapor 2.
| Device ID | K170358 |
| 510k Number | K170358 |
| Device Name: | Joimax Endovapor 2 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | joimax GmbH Amalienbadstr. 41, RaumFabrik 61 Karlsruhe, DE 76227 |
| Contact | Wolfgang Ries |
| Correspondent | Gary Mocnik Gary S. Mocnik And Associates 49 Coastal Oak Aliso Viejo, CA 92656 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-06 |
| Decision Date | 2017-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250337103974 | K170358 | 000 |
| 04250337105381 | K170358 | 000 |
| 04250337105398 | K170358 | 000 |
| 04250337111825 | K170358 | 000 |
| 04250337111832 | K170358 | 000 |
| 04250337114604 | K170358 | 000 |
| 04250337118848 | K170358 | 000 |
| 04250337120001 | K170358 | 000 |
| 04250337120018 | K170358 | 000 |
| 04250337120025 | K170358 | 000 |
| 04250337120032 | K170358 | 000 |
| 04250337120063 | K170358 | 000 |
| 04250337103967 | K170358 | 000 |