The following data is part of a premarket notification filed by Genicon, Inc. with the FDA for Aquas Probes.
| Device ID | K190168 |
| 510k Number | K190168 |
| Device Name: | Aquas Probes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Genicon, Inc. 6869 Stapoint Court Suite 114 Winter Park, FL 32792 |
| Contact | Katlyn Kachman |
| Correspondent | Katlyn Kachman Genicon, Inc. 6869 Stapoint Court Suite 114 Winter Park, FL 32792 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-31 |
| Decision Date | 2019-03-14 |