The following data is part of a premarket notification filed by Genicon, Inc with the FDA for X-surge.
| Device ID | K171752 |
| 510k Number | K171752 |
| Device Name: | X-SURGE |
| 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 | 2017-06-13 |
| Decision Date | 2017-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972007210 | K171752 | 000 |
| 00877972006732 | K171752 | 000 |
| 00877972006725 | K171752 | 000 |
| 00877972006695 | K171752 | 000 |
| 00877972006718 | K171752 | 000 |