The following data is part of a premarket notification filed by Apexum Ltd. with the FDA for Apexum Ablator.
| Device ID | K082325 |
| 510k Number | K082325 |
| Device Name: | APEXUM ABLATOR |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | APEXUM LTD. 6 YONI NETANYAHU ST. Or-yehuda, IL |
| Contact | Idan Tobis |
| Correspondent | Idan Tobis APEXUM LTD. 6 YONI NETANYAHU ST. Or-yehuda, IL |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-14 |
| Decision Date | 2009-04-21 |
| Summary: | summary |