The following data is part of a premarket notification filed by Microsulis Medical Limited with the FDA for Acculis Accu21 Pmta Microwave Tissue Ablation Applicator.
| Device ID | K122762 |
| 510k Number | K122762 |
| Device Name: | ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | MICROSULIS MEDICAL LIMITED UNIT 1 AND 2 FALSON COURT PARKLANDS BUSINESS PARK Denmead, GB Po7 7xp |
| Contact | Stuart Mcintyre |
| Correspondent | Stuart Mcintyre MICROSULIS MEDICAL LIMITED UNIT 1 AND 2 FALSON COURT PARKLANDS BUSINESS PARK Denmead, GB Po7 7xp |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-10 |
| Decision Date | 2012-11-30 |
| Summary: | summary |