The following data is part of a premarket notification filed by Medwaves Incorporated with the FDA for Avecure Microwave Coagulation-ablation Generator, Avecure Microwave Large Antenna-probe, Avecure Microwave Medium Antenna-probe, Avecure Microwave Small Antenna-probe, Avecure Microwave Mini Antenna-probe.
| Device ID | K143203 |
| 510k Number | K143203 |
| Device Name: | AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | MEDWAVES INCORPORATED 16760 WEST BERNARDO DRIVE San Diego, CA 92127 |
| Contact | Ted Ormsby |
| Correspondent | Ted Ormsby MEDWAVES INCORPORATED 16760 WEST BERNARDO DRIVE San Diego, CA 92127 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-07 |
| Decision Date | 2015-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858584002220 | K143203 | 000 |
| 00858584002022 | K143203 | 000 |
| 00858584002053 | K143203 | 000 |
| 00858584002077 | K143203 | 000 |
| 00858584002084 | K143203 | 000 |
| 00858584002091 | K143203 | 000 |
| 00858584002114 | K143203 | 000 |
| 00858584002138 | K143203 | 000 |
| 00858584002145 | K143203 | 000 |
| 00858584002152 | K143203 | 000 |
| 00858584002169 | K143203 | 000 |
| 00858584002176 | K143203 | 000 |
| 00858584002183 | K143203 | 000 |
| 00858584002190 | K143203 | 000 |
| 00858584002206 | K143203 | 000 |
| 00858584002213 | K143203 | 000 |
| 00858584002008 | K143203 | 000 |