K072687 is an FDA 510(k) clearance for the VALLEYLAB MICROWAVE ABLATION GENERATOR. This device is classified as a System, Ablation, Microwave And Accessories (Class II - Special Controls, product code NEY).
Submitted by Covidien Lp, Formerly Know AS Valleylab, A Divison (Boulder, US). The FDA issued a Cleared decision on November 25, 2008, 428 days after receiving the submission on September 24, 2007.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K072687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2007 |
| Decision Date | November 25, 2008 |
| Days to Decision | 428 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEY — System, Ablation, Microwave And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |