The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Joimax Electrosurgical Instruments.
| Device ID | K161378 |
| 510k Number | K161378 |
| Device Name: | Joimax Electrosurgical Instruments |
| 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 | 2016-05-18 |
| Decision Date | 2016-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250337116783 | K161378 | 000 |
| 04250337114413 | K161378 | 000 |
| 04250337114406 | K161378 | 000 |
| 04250337114390 | K161378 | 000 |
| 04250337114383 | K161378 | 000 |
| 04250337112631 | K161378 | 000 |
| 04250337112624 | K161378 | 000 |
| 04250337109563 | K161378 | 000 |
| 04250337105695 | K161378 | 000 |
| 04250337105626 | K161378 | 000 |
| 04250337104070 | K161378 | 000 |
| 04250337104049 | K161378 | 000 |
| 04250337103912 | K161378 | 000 |
| 04250337120100 | K161378 | 000 |
| 04250337103820 | K161378 | 000 |
| 04250337103776 | K161378 | 000 |
| 04250337103585 | K161378 | 000 |
| 04250337119999 | K161378 | 000 |
| 04250350109274 | K161378 | 000 |
| 04250337103752 | K161378 | 000 |
| 04250337116271 | K161378 | 000 |
| 04250337116073 | K161378 | 000 |
| 04250337115243 | K161378 | 000 |
| 04250337113867 | K161378 | 000 |
| 04250337113850 | K161378 | 000 |
| 04250337105206 | K161378 | 000 |
| 04250337104056 | K161378 | 000 |
| 04250337104032 | K161378 | 000 |
| 04250337103905 | K161378 | 000 |
| 04250337103899 | K161378 | 000 |
| 04250337103882 | K161378 | 000 |
| 04250337103875 | K161378 | 000 |
| 04250337103844 | K161378 | 000 |
| 04250337103813 | K161378 | 000 |
| 04250337103806 | K161378 | 000 |
| 04250337103783 | K161378 | 000 |
| 04250337103578 | K161378 | 000 |